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Argo Bagz Fluid Management Systems
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 197530
Identity
- Trade Name
- Argo Bagz Fluid Management Systems EUDAMEDFDA UDIArgo Bagz Fluid Management System FDA UDI
- Generic Name
- Fluid transfer set, general-purpose FDA UDI
- Device Name
- Argo Bagz Fluid Management Systems EUDAMEDFDA UDIArgo Bagz Fluid Management System FDA UDI
- Model / Reference
- 197530 EUDAMEDFDA UDI197540 FDA UDI
- Description
- Argo Bagz Fluid Management Systems FDA UDIArgo Bagz Fluid Management System FDA UDI
Identifiers
- Catalog Number
- 197540 FDA UDI197530 FDA UDI
- Primary DI / UDI-DI
- 20886333208696 EUDAMED00886333208722 FDA UDI00886333208692 FDA UDI
- Basic UDI-DI
- B-20886333208696 EUDAMED
- 510(k) Number
- K904994 FDA UDI
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A0680 DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Fluid transfer set, general-purpose FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 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
Yes
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: Fluid transfer set, general-purpose
Argo Bagz Fluid Management Systems by Argon Medical Devices, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
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 (3)
- FDA UDI 1b071700-24e1-44af-a175-5d37c2b1e828 36 fields · synced Jul 27, 2026
- FDA UDI da329021-c1e6-4a2b-8c9d-6b9f4cb469d8 36 fields · synced May 30, 2026
- EUDAMED 574f7c9c-af4f-4ac1-a7f8-28cb51f67215 61 fields · synced Jul 27, 2026