Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015058854

FEI Number

3015058854

Entity Name

JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD.

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

Rm.1101 Blvd.#1, Tianning Shidai Plaza, Changzhou Jiangsu 213000, CN

Establishment Type(s)

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

Owner / Operator

New Pentastar Medical Products Co. Limited (Owner Number: 10063374)

Owner / Operator Contact Address

FLAT C 9/F Winning House 72-76 Wing Lok Street, Sheung Wan, HK, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

laparoscopy kit Central Line Trays; Convenience Kits; Dressing change kit; instrument pack; Irrigation tray; IV START KIT; Laceration Tray; Shave Prep Kit; skin scrub Tray; Tracheostomy Care Tray CATHETER AND TIP, SUCTION Mask, surgical, Face mask, Surgical masks, Urinary drainage collection kit, for indwelling catheter TRAY, SURGICAL, INSTRUMENT ASAL OXYGEN CANNULA, OXYGEN CANNULA OR Towel, Gauze, Wipes Collagen Wound Dressing Walker, mechanical First aid kit without drug CAP, SURGICAL, Bouffant Caps, clip caps CRUTCH BASIN, EMESIS BANDAGE, ELASTIC, Cohesive Bandage; ESMARK BANDAGE,Conforming Bandage, Elastic Crepe Bandage CONTAINER, SPECIMEN, STERILE STETHOSCOPE, MANUAL STAND, INFUSION SYRINGE, IRRIGATING (NON DENTAL), IRRIGATOR Silicone hydrogel for scar management DEVICE, PASTE-ON FOR INCONTINENCE, NON-STERILE MASK, OXYGEN EXERCISER, NON-MEASURING Isolation Face Shield, Isolation Face Mask, Medical Face Shield, Medical Shield, Face Shield Luer Access Device-holder with Preattached Multiple Sample Adapter Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Surgical gown BRUSH, CLEANING, TRACHEAL TUBE Pad, alcohol, device disinfectant SUPPORT, PATIENT POSITION Drape, microscope, ophthalmic CATHETER, IRRIGATION Device, fixation, tracheal tube AID, TRANSFER Circuit, breathing (w connector, adaptor, y piece) dressing, compression CONTAINER, SPECIMEN, NON-STERILE Counter, sponge, surgical Stocking, medical support (to prevent pooling of blood in legs) Drape, surgical, exempt Powder Free Nitrile Examination Glove MASK, OXYGEN, LOW CONCENTRATION, VENTURI Dental cup, Denture Cup Syringe, piston NEBULIZER BOTTLE SET ACCESSORIES, CATHETER, CATHETER HOLDER, CATHETER STRIP SLING, ARM bedding, disposable, medical - BED COVERS; BED SHEETS; NON WOVEN BEDSHEETS/COVERS; PILLOW CASES Urine (And Accessories) For Indwelling catheter, Urinary drainageBag hold collector, urine, (and accessories) for indwelling catheter - BAG, URINARY LEG W/STRAPS, LEG BAG; Collector, SURGICAL MASK Dressing, wound, hydrophilic Skin and Wound Cleanser Enema bag, Enema kit, Enema Bag Set w/soaps; ENEMA BUCKET 1500ML W/SOAP; ENEMA SET SHOE AND SHOE COVER, CONDUCTIVE CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE CHAIR, WITH CASTERS Mattress, air flotation, alternating pressure CANE AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY Isolation gown, Protective gown, exam gown. ,Non-surgical gown DEPRESSOR, TONGUE, NON-SURGICAL apparatus, suction, single patient use, portable, nonpowered infusor, pressure, for i.v. bags - PRESSURE INFUSOR FOR AN I.V. BAG Safety lancet, personal protection kit CATHETER, NASAL, OXYGEN IPS AND PADS, CANE, CRUTCH AND WALKER tubing, noninvasive solvent, adhesive tape - Adhesive Remover Pad NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) disinfectant, medical devices - alcohol wipe SPECULUM, NON-ILLUMINATED Endotracheal Tube CHAIR, WITH CASTERS Gluco-Monitoring System MASK, OXYGEN, NON-REBREATHING SUCTION CATHETER Light, surgical, accessories, LIGHT HANDLE COVER COVER, MATTRESS (MEDICAL PURPOSES) Electrode, electrocardiograph drape, adhesive, aerosol - Disposable Surgical Drape Set, administration, intravascular I.V. Administration Set Safety lancet Wheelchair, mechanical Suture removal kit closure, wound, adhesive - Wound plaster BAG, RESERVOIR Pediatric Urine bag Paste-on,PASTE-ON FOR INCONTINENCE, Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder dispenser, solid medication - pill dispenser, pill box AIRWAY, NASOPHARYNGEAL Safety Sliding Blood Collection Set, Safety Butterfly Blood Collection Set, Sliding Blood Collection Set ACCESSORY, SURGICAL APPAREL Anesthesia breathing circuit kit (adult & pediatric) MARKER, SKIN Sharps Container shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) - Protective Goggles; Gelling Fiber Wound Dressing catheter, ventricular, general & plastic surgery - Introduction/Drainage Catheter & Accessories URINAL BOTTLE, URINAL, BANDAGE, CAST, POP bandage, Casting bandage, Casting splint, Cast Paddings; Casting Tapes; Plaster Bandage; Stockinette SURGICAL GOWN CHAIR AND TABLE, MEDICAL IV Catheter, intravascular, therapeutic, short-term less than 30 days Continuous Measurement Thermometer bag, urine collection, leg, for external use, MASK, GAS, ANESTHETIC APPLICATOR, ABSORBENT TIPPED, STERILE; Specimen Collection Swab sterile absorber, saliva, paper - Denal Apron; Dental bibs, Patient Bibs device, urine flow rate measuring, non-electrical, disposable - device, urine flow rate measuring non-electrical, disposable - Urinemeters Boot Cover; Disposable Slipper; Shoe Cover; Sleeve Cover Massage Slippers; socks Strip, adhesive, closure, skin, Suture strip, WOUND CLOSURE STRIPS hydrocolloid foam dressing; nonwoven wound dressing; silicone dressing; silicone foam dressing; s super absorbency dressing; transparent island dressing dressing, wound, occlusive - foam dressing; Freevent Dressing SoftFoam; Heel foam dressing; hydrocolloid dressing; TOURNIQUET, NONPNEUMATIC Lancet first aid kit with drug PACK, HOT OR COLD, DISPOSABLE Gown, examination, exma gown, paper exam gown

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2024-01-02
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2020-07-09
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2024-01-23
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-08-06
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2020-07-09
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-10-29
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2020-03-20
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2023-11-29
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-04-26
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2024-10-29
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2024-01-02
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-20
IPR	Crutch	Physical Medicine	Class 1	890.3150	2024-10-29
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2020-03-20
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-03-20
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2020-07-09
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2020-07-16
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2024-10-29
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2020-03-20
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2024-01-02
NOA	Device, Paste-On For Incontinence, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2020-07-09
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2023-04-05
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2024-10-29
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2020-03-20
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2022-04-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-04-20
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-07-24
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2024-10-23
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2026-01-14
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2023-04-06
HMW	Drape, Microscope, Ophthalmic	General, Plastic Surgery	Class 2	878.4370	2023-12-07
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2024-10-23
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2021-05-20
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2024-10-29
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2024-10-23
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2024-01-02
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-07-09
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2024-04-08
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2024-12-05
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2023-12-07
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2026-04-27
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2026-04-27
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2026-04-27
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2026-04-27
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2024-10-23
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2026-05-12
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-01-29
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-04-04
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2020-07-09
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2024-10-16
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2020-03-20
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2020-07-09
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-20
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-01-02
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-04-26
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2020-07-09
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2020-03-20
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2021-03-05
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2024-10-23
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2023-09-12
IPS	Cane	Physical Medicine	Class 1	890.3075	2024-10-29
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2024-10-23
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-20
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2020-03-20
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2020-07-09
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2023-07-07
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-06-08
PXC	Personal Protection Kit	General Hospital	Class 1	880.6250	2025-07-28
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2024-05-17
INP	Tips And Pads, Cane, Crutch And Walker	Physical Medicine	Class 1	890.3790	2023-12-11
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2024-10-31
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2026-01-14
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2020-07-08
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2026-01-03
FXE	Speculum, Non-Illuminated	General, Plastic Surgery	Class 1	878.1800	2020-06-26
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2024-10-31
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2024-10-29
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2023-04-05
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2023-04-05
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2023-04-05
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2024-10-23
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2020-07-08
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2022-03-11
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2020-07-09
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2024-12-02
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2023-12-07
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-01-29
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-06-14
IOR	Wheelchair, Mechanical	Physical Medicine	Class 1	890.3850	2023-12-11
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2024-01-23
MGO	Closure, Wound, Adhesive	General, Plastic Surgery	Class 1	878.4018	2024-10-16
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2024-10-23
EXI	Device, Paste-On For Incontinence, Sterile	Gastroenterology, Urology	Class 1	876.5250	2020-07-09
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2022-09-19
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-07-25
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2024-10-29
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2024-10-23
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-04-14
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-22
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	Class 1	868.5240	2024-10-23
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2023-09-12
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2023-04-05
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-20
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-04-26
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2024-01-18
FNP	Urinal	General Hospital	Class 1	880.6730	2023-07-06
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2020-03-20
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-12-19
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2024-10-29
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2023-03-21
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-06-28
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2020-07-09
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2025-07-28
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2025-07-02
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2022-08-17
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2020-07-09
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2026-06-01
FPX	Strip, Adhesive, Closure, Skin	General Hospital	Class 1	880.5240	2024-03-27
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-10-16
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2020-03-20
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-06-14
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2023-06-14
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2026-05-13
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2020-07-21
FME	Gown, Examination	General Hospital	Class 1	880.6265	2021-03-05

Official Correspondent

Owen Luo

US Agent Details

Mel Torres Business: BRIDON CORP Email: mquiles@bridoncorp.com Phone: (787) 4554150

Related Public Records

Same Entity

New Pentastar Medical Products Co. Limited

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015058854. Last updated year: 2026. Please use registration number 3015058854 when referencing this establishment in official correspondence.