Argo Bagz Fluid Management Systems

FDA UDI

Class II (US FDA UDI)

by Argon Medical Devices, Inc.

Identity

Trade Name: Argo Bagz Fluid Management Systems FDA UDI
Generic Name: Fluid transfer set, general-purpose FDA UDI
Device Name: Argo Bagz Fluid Management Systems FDA UDI
Model / Reference: 197580 FDA UDI
Description: Argo Bagz Fluid Management Systems FDA UDI

Identifiers

Catalog Number: 197580 FDA UDI
Primary DI / UDI-DI: 00886333208753 FDA UDI
510(k) Number: K904994 FDA UDI
FDA Product Code: DXT FDA UDI
GMDN Term: Fluid transfer set, general-purpose FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K904994 also covers:

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: Argon Medical Devices, Inc.

Sources (1)

FDA UDI 9a97b092-ac34-407e-b5ce-9ab06d3a4d3c 36 fields · synced Jun 9, 2026