SAINT JONES MANAGEMENT LP EOOD

FDA Device Registration & Listing · Sofia Sofia-Grad, BG · Registration 3016904853

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016904853
FEI Number
3016904853
Entity Name
SAINT JONES MANAGEMENT LP EOOD
City/State/Country
Sofia Sofia-Grad, BG
Establishment Address
Stefan Kirov 42, Sofia Sofia-Grad 1111, BG
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Saint Jones Management LP EOOD (Owner Number: 10074449)
Owner / Operator Contact Address
Stefan Kirov 42, Sofia, BG-22 1111, BG
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES SAINT JONES

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2023-06-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-06-06
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2024-12-23
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-05-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-09-06
BYD Condenser, Heat And Moisture (Artificial Nose) Anesthesiology Class 1 868.5375 2025-09-08
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-05-22
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2025-02-21
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2024-02-22
MEG Syringe, Antistick General Hospital Class 2 880.5860 2024-05-22
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-05-22
KMI Monitor, Bed Patient General Hospital Class 1 880.2400 2025-11-24
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-11-25
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2025-11-25
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2025-11-25
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-10-07
BSF Absorber, Carbon-Dioxide Anesthesiology Class 1 868.5310 2022-02-17
NPP Reprocessed Blood Pressure Cuff Cardiovascular Class 2 870.1120 2023-11-07
FSR Light, Headband, Surgical Ophthalmic Class 2 886.4335 2025-08-12
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2024-02-22
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-06-06
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-06-06
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2024-05-22
HOZ Sponge, Ophthalmic Ophthalmic Class 2 886.4790 2025-11-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-04-13
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-11-07
MEG Syringe, Antistick General Hospital Class 2 880.5860 2023-11-07
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-11-25
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2023-11-03
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-11-25
KDT Container, Specimen Mailer And Storage, Sterile Pathology Class 1 864.3250 2023-11-07
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2024-02-22
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2025-11-24
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2025-05-20
FTD Lamp, Surgical General, Plastic Surgery Class 2 878.4580 2024-12-19
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-08-31
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2026-01-15
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2026-01-15
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-04-13
LDE Stethoscope, Manual Cardiovascular Class 1 870.1875 2025-11-25
FQM Bandage, Elastic General Hospital Class 1 880.5075 2024-05-22
MEG Syringe, Antistick General Hospital Class 2 880.5860 2022-10-10
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2024-12-02
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2022-10-10
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-08-31
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-02-22
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2025-11-24
FPB Filter, Infusion Line General Hospital Class 2 880.5440 2026-01-15
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2025-05-06
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2023-11-07
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2025-05-06
JEQ Toothbrush, Powered Dental Class 1 872.6865 2020-05-26
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2023-06-06
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2022-10-10
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-10-22
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-06-06
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-11-24
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2024-08-09
JYK Holder, Ear Speculum General, Plastic Surgery Class 1 878.1800 2025-05-20
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2025-11-25
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2024-05-22
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-10-22
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2025-05-06
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-05-06
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-08-13
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2025-05-20
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2024-12-17
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2024-05-22
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2025-05-06
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2025-11-24

Official Correspondent

Daniel Rizov

US Agent Details

IGNACIO AGOTE Business: SOUTHEASTERN INTERNATIONAL GROUP LLC Email: iagote@secargousa.com Phone: (954) 5233855

Related Public Records

Same Entity

Saint Jones Management LP EOOD
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
K943349 Quinton, Inc. MAHURKAR DUAL LUMEN CATHETER 1995-03-22
K912158 Medical Device Inspection Co., Inc. CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY 1991-10-23
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26
K122854 Arrow International (Subsidiary of Teleflex Inc.) ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER 2013-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2024 ARROW INTERNATIONAL Inc. 2
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024 ARROW INTERNATIONAL Inc. 2
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023 B Braun Medical Inc 2
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024 Becton Dickinson Infusion Therapy Systems Inc. 2
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016904853. Last updated year: 2026. Please use registration number 3016904853 when referencing this establishment in official correspondence.
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