Identity
- Trade Name
- UNBRANDED FDA UDI
- Generic Name
- Extracorporeal circuit waste bag FDA UDI
- Device Name
- Urologic Drain Bag FDA UDI
- Model / Reference
- 056397-909 FDA UDI
- Description
- Urologic Drain Bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848340009471 FDA UDI
- 510(k) Number
- K012168 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Extracorporeal circuit waste bag FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
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
Ethylene Oxide FDA UDI
Category: Extracorporeal circuit waste bag
Unbranded by Advance Medical Designs, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extracorporeal circuit waste bag.
- Medex — ICU MEDICAL, INC. · Class II
- Cycler Drain Bag Set — Fresenius Medical Care Holdings, Inc. · Class II
- stay.safe® — Fresenius Medical Care Holdings, Inc. · Class II
- XTRA — SORIN GROUP ITALIA SRL · Class II
- Medex — ICU MEDICAL, INC. · Class II
- AUTO EFFLUENT SET — Gambro UF Solutions LLC · Class I
- Procedure Products waste bags — PROCEDURE PRODUCTS, INC. · Class II
- Medex — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K012168 also covers:
- Easy Catcher — Advance Medical Designs, Inc.
- Easy Catcher — Advance Medical Designs, Inc.
- Easy Catcher — Advance Medical Designs, Inc.
- Easy Catcher — Advance Medical Designs, Inc.
- UNBRANDED — Advance Medical Designs, Inc.
- UNBRANDED — Advance Medical Designs, Inc.
- UNBRANDED — Advance Medical Designs, Inc.
- UNBRANDED — Advance Medical Designs, Inc.
- UNBRANDED — Advance Medical Designs, Inc.
- UNBRANDED — Advance Medical Designs, Inc.
- UNBRANDED — Advance Medical Designs, Inc.
- UNBRANDED — Advance Medical Designs, 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
- Advance Medical Designs, Inc.
Sources (1)
- FDA UDI a12becad-b9e4-431b-b646-cb9d6e466641 34 fields · synced Jun 8, 2026