Identity
- Trade Name
- Flexicare FDA UDI
- Generic Name
- Urine flowmeter, single-use FDA UDI
- Device Name
- UriMeter 1.5m Inlet Tube Sterile FDA UDI
- Model / Reference
- 00-1227U FDA UDI
- Description
- UriMeter 1.5m Inlet Tube Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788767121 FDA UDI
- FDA Product Code
- EXR FDA UDI
- GMDN Term
- Urine flowmeter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine flowmeter, single-use
Flexicare by Flexicare Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine flowmeter, single-use.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Dover — Cardinalhealth · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Dover — Cardinal Health 200, LLC · Class II
- AMSure® Urine Meter Drainage Bag — AMSINO INTERNATIONAL, INC. · Class II
- CarePath — Cleartrac Technologies, LLC · Class II
- Dover — Cardinalhealth · Class II
- MEDLINE — MEDLINE INDUSTRIES, 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
- Flexicare Medical Limited
Sources (1)
- FDA UDI 0902496e-f32c-413d-979e-3c4a75effe74 33 fields · synced May 30, 2026