Criticath(tm) Sp5537h-13 Pacing Catheter

FDA UDI

Class II (US FDA UDI)

by Argon Critical Care Systems Singapore Pte. Ltd.

Identity

Trade Name: CRITICATH(TM) SP5537H-13 PACING CATHETER FDA UDI
Generic Name: Pulmonary artery balloon catheter, electrical FDA UDI
Device Name: Heparin coated Catheter7.5FR, 5 Lumen with length 110 cm FDA UDI
Model / Reference: 680072 FDA UDI
Description: Heparin coated Catheter7.5FR, 5 Lumen with length 110 cm FDA UDI

Identifiers

Catalog Number: 680072 FDA UDI
Primary DI / UDI-DI: 00886333600724 FDA UDI
FDA Product Code: KRB FDA UDI
GMDN Term: Pulmonary artery balloon catheter, electrical FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1915 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

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

FDA UDI

Category: Pulmonary artery balloon catheter, electrical

Criticath(tm) Sp5537h-13 Pacing Catheter by Argon Critical Care Systems Singapore Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID

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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 Critical Care Systems Singapore Pte. Ltd.

Sources (1)

FDA UDI ae37d688-29e6-4aea-b77c-e2a6c68b193d 36 fields · synced May 30, 2026