Identity
- Trade Name
- Mckesson FDA UDI
- Generic Name
- Intermittent urethral drainage catheter, non-antimicrobial, reusable FDA UDI
- Device Name
- Intermittent Catheter HYDROPHILIC | STERILE WATER PACKET STRAIGHT TIP | MALE/UNIVERSAL | PVC | STERILE 16 Inch 16 Fr FDA UDI
- Model / Reference
- 16-MH1616 FDA UDI
- Description
- Intermittent Catheter HYDROPHILIC | STERILE WATER PACKET STRAIGHT TIP | MALE/UNIVERSAL | PVC | STERILE 16 Inch 16 Fr FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10612479242736 FDA UDI
- 510(k) Number
- K111405 FDA UDI
- FDA Product Code
- GBM FDA UDI
- GMDN Term
- Intermittent urethral drainage catheter, non-antimicrobial, reusable 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
Yes
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: Intermittent urethral drainage catheter, non-antimicrobial, reusable
Mckesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, reusable.
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Dover — Cardinal Health 200, LLC · Class II
- AMSure® PVC Intermittent Catheter — AMSINO INTERNATIONAL, INC. · Class II
- Dover — Cardinal Health 200, LLC · Class II
- Dover — Cardinalhealth · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class I
Cleared under the same submission
K111405 also covers:
- TruCath — H R Pharmaceuticals, Inc.
- TruCath — H R Pharmaceuticals, Inc.
- TruCath — H R Pharmaceuticals, Inc.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL 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
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI f8941b6f-26d2-4079-87f3-4860fa39f9cb 34 fields · synced May 30, 2026