COULMED PRODUCTS GROUP LLC

FDA Device Registration & Listing · Springfield, NJ, US · Registration 3015625160

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
3015625160
FEI Number
3015625160
Entity Name
COULMED PRODUCTS GROUP LLC
City/State/Country
Springfield, NJ, US
Establishment Address
44 Commerce Street, Springfield, NJ 07081, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Coulmed Products Group LLC (Owner Number: 10076284)
Owner / Operator Contact Address
44 Commerce Street, Springfield, NJ 07081, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Coulmed Products Coulmed Products Coulmed Products Coulmed Products Coulmed Products Coulmed Products Coulmed Products Coulmed Products

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LWG Surgical Table Cushion General, Plastic Surgery Class 1 878.4950 2022-09-27
EYH Table, Cysto, Non-Electrical Gastroenterology, Urology Class 1 876.4890 2024-06-27
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2022-01-04
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2022-09-27
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2022-09-22
FAQ Bag, Urine Collection, Leg, For External Use, Sterile Gastroenterology, Urology Class 1 876.5250 2022-10-18
NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2022-09-27
NNZ System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2025-01-15

Official Correspondent

Calvin MacDougall

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Coulmed Products Group LLC
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
K914369 Deroyal Industries, Inc. QUALTEX MAGNETIC INSTRUMENT DRAPE 1991-12-02
K812809 Abco Dealers, Inc. STERILE ADHERENT DRAPES 1981-11-06
K910084 Biocor Medical, Inc. SURGICAL DRAPE 1991-03-19

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1528695 CASCO MANUFACTURING SOLUTIONS, INC. Cincinnati, OH, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015625160. Last updated year: 2026. Please use registration number 3015625160 when referencing this establishment in official correspondence.
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