Identity
- Trade Name
- TMM-FC FDA UDI
- Generic Name
- Indwelling urethral catheterization kit, adult FDA UDI
- Model / Reference
- 05006 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850062467033 FDA UDI
- FDA Product Code
- OHR 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Indwelling urethral catheterization kit, adult
Tmm-Fc by Altitude Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Indwelling urethral catheterization kit, adult.
- Bard® Drain Bag Foley Tray with Bardex® All-Silicone Catheter — C. R. Bard, Inc. · Class II
- Dover — Cardinalhealth · Class II
- 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
- NURSE ASSIST — NURSE ASSIST, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Altitude Technologies Inc.
Sources (1)
- FDA UDI ede2b6c2-40e0-41e9-bb5e-f9d31645857b 32 fields · synced Jun 8, 2026