Identity
- Trade Name
- Dover FDA UDI
- Generic Name
- Urine flowmeter, single-use FDA UDI
- Device Name
- Urine Meter Drainage Bag FDA UDI
- Model / Reference
- 8101 FDA UDI
- Description
- Urine Meter Drainage Bag FDA UDI
Identifiers
- Catalog Number
- 8101 FDA UDI
- Primary DI / UDI-DI
- 10884521025691 FDA UDI
- FDA Product Code
- KNX FDA UDI
- GMDN Term
- Urine flowmeter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5250 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 2000 Milliliter FDA UDI
Category: Urine flowmeter, single-use
Dover by Cardinalhealth — 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
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Dover — Cardinal Health 200, LLC · Class II
- AMSure® Urine Meter Drainage Bag — AMSINO INTERNATIONAL, INC. · Class II
- Flexicare — FLEXICARE MEDICAL LIMITED · Class II
- CarePath — Cleartrac Technologies, LLC · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Dover — Cardinal Health 200, LLC · 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 |
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Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA UDI f1baa2e2-b4a5-4dc0-a438-97d51b98282f 37 fields · synced May 30, 2026