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Careflow(tm) 1 Lumen 4fr X 200mm

FDA UDI

Class II (US FDA UDI)

by Argon Critical Care Systems Singapore Pte. Ltd.

Identity

Trade Name
CAREFLOW(TM) 1 LUMEN 4FR X 200MM FDA UDI
Generic Name
Arterial blood pressure catheter FDA UDI
Device Name
Kits contents: Catheter 4FR OD 1.45mmx200mm, J guidewire OD 0.64x450mm, Steel Needle Introducer 17G OD 1.4mmx70mm. FDA UDI
Model / Reference
681648 FDA UDI
Description
Kits contents: Catheter 4FR OD 1.45mmx200mm, J guidewire OD 0.64x450mm, Steel Needle Introducer 17G OD 1.4mmx70mm. FDA UDI

Identifiers

Catalog Number
681648 FDA UDI
Primary DI / UDI-DI
00886333616480 FDA UDI
FDA Product Code
FOZ FDA UDI
GMDN Term
Arterial blood pressure catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5200 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Category: Arterial blood pressure catheter

Careflow(tm) 1 Lumen 4fr X 200mm by Argon Critical Care Systems Singapore Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arterial blood pressure catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Argon Critical Care Systems Singapore Pte. Ltd.

Sources (1)

  • FDA UDI 43b09362-a9c0-41f6-8267-fd90a5af3488 36 fields · synced May 30, 2026