Identity
- Trade Name
- Drainage Bag EUDAMEDFDA UDI
- Generic Name
- Bile collection bag FDA UDI
- Device Name
- Drainage Bag EUDAMEDDrainage Bag 600ml FDA UDI
- Model / Reference
- DBAG600 EUDAMEDFDA UDI
- Description
- Drainage Bag 600ml FDA UDI
Identifiers
- Catalog Number
- DBAG600 FDA UDI
- Primary DI / UDI-DI
- 20886333001426 EUDAMED00886333001422 FDA UDI
- Basic UDI-DI
- B-20886333001426 EUDAMED
- 510(k) Number
- K980005 FDA UDI
- FDA Product Code
- EXF FDA UDI
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
- GMDN Term
- Bile collection bag FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Category: Bile collection bag
Drainage Bag by Argon Medical Devices, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bile collection bag.
- Drainage Bag — REMINGTON MEDICAL, INC. · Class II
- Drainage Bag — Argon Medical Devices, Inc. · Class II
Cleared under the same submission
K980005 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Argon Medical Devices, Inc.
Sources (2)
- FDA UDI 00bac574-5ef3-4cd8-9285-f1aeb14d25b7 37 fields · synced Oct 6, 2026
- EUDAMED 6078e3e8-83f1-41f7-bffb-9fb6c66f438b 61 fields · synced Oct 6, 2026