Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014579161

FEI Number

3014579161

Entity Name

WORLDWIDE SUPPLIES LIMITED

City/State/Country

Hong Kong, HK

Establishment Address

50 Bonham Strand, NO.5, 17/F Bonham Trade Centre, Hong Kong none, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Worldwide Supplies Limited (Owner Number: 10057941)

Owner / Operator Contact Address

50 Bonham Strand, NO.5, 17/F Bonham Trade Centre, Hong Kong, HK-NOTA none, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K964853

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUK	Administration Set Securement Device	General Hospital	Class 1	880.5210	2025-11-17
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2024-02-27
HGE	Amniotome	Obstetrics/Gynecology	Class 1	884.4530	2025-05-01
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2025-06-05
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2025-03-31
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2026-06-15
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2025-06-05
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2024-01-08
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2026-06-09
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2026-02-12
HJN	Transilluminator, Battery-Powered	Ophthalmic	Class 1	886.1945	2024-08-09
FKK	Clamp, Line	Gastroenterology, Urology	Class 1	876.4730	2025-08-29
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-12-11
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-06-15
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2025-05-01
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-06-15
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2026-04-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-04-13
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2023-06-01
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2019-05-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-05-01
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2026-02-12
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2026-06-15
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2026-04-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-04-13
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2026-03-31
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2025-09-19
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2025-09-19
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2026-05-29
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-01-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-01-08
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-01-08
QAU	Hemostatic Device For Endoscopic Gastrointestinal Use	General, Plastic Surgery	Class 2	878.4456	2026-01-19
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2025-08-29
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2025-08-29
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-06-15
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2025-11-17
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2026-06-10
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-06-25
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2023-03-13
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2025-12-10
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2026-06-10
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-11-26
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2019-02-01
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2024-03-01
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2026-03-31
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-08-28
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-08-28
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-08-28
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2026-04-23
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-07-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-08-15
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2025-07-30
ELW	Material, Impression	Dental	Class 2	872.3660	2026-06-15
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2025-04-30
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2024-09-25
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2026-05-29
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2025-06-25
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2026-05-12
EKB	Explorer, Operative	Dental	Class 1	872.4565	2026-04-27
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-04-03
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2026-02-03
LHC	Warmer, Irrigation Solution	Physical Medicine	Class 1	890.5950	2023-05-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-03-13
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2024-09-25
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-11-17
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-09-09
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2024-02-20
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2024-10-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-12-02
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2024-09-25
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2026-02-12
GXB	Esthesiometer	Neurology	Class 1	882.1500	2026-05-29
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2025-05-01
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2026-02-03
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2025-12-02
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-03-24
GCW	Transformer, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2025-07-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-02-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-05-15
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2025-06-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-08-15
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2026-06-15
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2026-06-10
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-12-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-04-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-04-15
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-04-15
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2026-01-28
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-12-01
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2025-05-01
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2025-12-02
DQD	Stethoscope, Electronic	Cardiovascular	Class 2	870.1875	2026-06-15
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2026-04-07
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2024-10-07
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-07-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-04-28
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-06-15
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2025-06-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2026-05-29
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2026-05-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-02-12
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2024-09-25
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2026-04-23
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-07-17
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2018-08-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-29
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2024-07-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-07-30
JKS	Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2024-07-30
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2025-07-01
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2026-04-07
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-06-14
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	2025-07-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-07-11
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2025-07-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-07-11
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2025-07-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-07-11
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-01-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-08-28
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-08-28
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2024-12-18
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2018-08-07
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2020-08-20
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2024-08-15
HKM	Retinoscope, Battery-Powered	Ophthalmic	Class 1	886.1780	2024-06-24
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-05-01
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2026-04-27
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-08-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-06-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-05-01
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2023-07-25
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2019-11-06
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2023-06-06
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2026-06-10
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2025-05-09
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-05-14
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2025-07-30
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-05-14
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2025-06-25
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2023-06-05
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-06-04
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-02-26
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2025-06-16
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2024-05-17
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2025-12-10
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2025-12-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-12-02
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2024-04-12
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2019-07-22
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2026-06-15
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-06-14
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2025-09-22
CAD	Vaporizer, Anesthesia, Non-Heated	Anesthesiology	Class 2	868.5880	2026-06-15
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2025-06-05
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-05-01
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2026-04-27
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-08-09
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2026-06-15
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2023-12-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-01-02
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-01-02
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-07-25
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-07-25
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2025-06-05
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2023-05-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-06-15
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2026-06-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-11-02
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2023-02-23
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-09-08
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2019-11-06
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2024-10-21
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2019-02-01
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-03-24
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2026-02-03
HLS	Exophthalmometer	Ophthalmic	Class 1	886.1270	2024-04-03
EZR	Cement, Stomal Appliance, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2018-09-02
EXH	Bag, Urinary, Ileostomy	Gastroenterology, Urology	Class 1	876.5900	2026-06-15
EMA	Cement, Dental	Dental	Class 2	872.3275	2026-04-30
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2025-01-31
EJY	Pliers, Operative	Dental	Class 1	872.4565	2026-04-27
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2026-04-27
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-05-19
EMA	Cement, Dental	Dental	Class 2	872.3275	2025-12-02
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2026-01-12
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2024-09-25
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2024-09-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-12-10
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2023-03-13

Official Correspondent

No official correspondent registered.

US Agent Details

ZEVY HOFFMAN Email: HOFFMANZEVY@GMAIL.COM Phone: (845) 3711718

Related Public Records

Same Entity

Worldwide Supplies Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K993974	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR	2000-02-22
K182075	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	2018-12-10
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20
K972535	Odam	MAGLIFE C	1998-01-13
K170567	Remote Diagnostic Technologies , Ltd.	Tempus Pro Patient Monitor	2017-07-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Z-1321-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Z-1666-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Z-1729-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014579161. Last updated year: 2026. Please use registration number 3014579161 when referencing this establishment in official correspondence.