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Criticath(tm) Sp5325hl Monitoring Catheter

FDA UDI

Class II (US FDA UDI)

by Argon Critical Care Systems Singapore Pte. Ltd.

Identity

Trade Name
CRITICATH(TM) SP5325HL MONITORING CATHETER FDA UDI
Generic Name
Pulmonary artery balloon catheter, non-electrical FDA UDI
Device Name
Catheter 5FR, 2 Lumen with length 110cm FDA UDI
Model / Reference
680057 FDA UDI
Description
Catheter 5FR, 2 Lumen with length 110cm FDA UDI

Identifiers

Catalog Number
680057 FDA UDI
Primary DI / UDI-DI
00886333600571 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Pulmonary artery balloon catheter, non-electrical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

Yes

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: Pulmonary artery balloon catheter, non-electrical

Criticath(tm) Sp5325hl Monitoring Catheter by Argon Critical Care Systems Singapore Pte. Ltd. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Pulmonary artery balloon catheter, non-electrical.

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 d7614851-7ce2-4ab5-97ec-42a30d2d4d4f 36 fields · synced May 30, 2026