Identity
- Trade Name
- MCKESSON FDA UDI
- Generic Name
- Indwelling urethral catheterization kit, adult FDA UDI
- Device Name
- 14 FR RED RUBBER CATHETER-FORCEPS PROCEDURE FDA UDI
- Model / Reference
- 37-202 FDA UDI
- Description
- 14 FR RED RUBBER CATHETER-FORCEPS PROCEDURE FDA UDI
Identifiers
- Primary DI / UDI-DI
- B150372020 FDA UDI
- 510(k) Number
- K904158 FDA UDI
- FDA Product Code
- FCM FDA UDI
- GMDN Term
- Indwelling urethral catheterization kit, adult FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Indwelling urethral catheterization kit, adult
Mckesson by Nurse Assist, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Indwelling urethral catheterization kit, adult.
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- Dover — Cardinalhealth · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Dover — Cardinal Health 200, LLC · Class II
- Dover — Cardinal Health 200, LLC · Class II
- Dover — Cardinalhealth · Class II
- Bardex® I.C. Foley Catheter Tray — C. R. Bard, Inc. · Class II
Cleared under the same submission
K904158 also covers:
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- MCKESSON — NURSE ASSIST, INC.
- MCKESSON — NURSE ASSIST, INC.
- MCKESSON — NURSE ASSIST, INC.
- MCKESSON — NURSE ASSIST, INC.
- NURSE ASSIST — NURSE ASSIST, INC.
- NURSE ASSIST — NURSE ASSIST, INC.
- NURSE ASSIST — NURSE ASSIST, INC.
- NURSE ASSIST — NURSE ASSIST, INC.
- NURSE ASSIST — NURSE ASSIST, INC.
- NURSE ASSIST — NURSE ASSIST, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nurse Assist, Inc.
Sources (1)
- FDA UDI fc13e035-8166-4ea8-a698-d9461a197057 34 fields · synced Jun 8, 2026