← Back to catalogue

Criticath(tm) Sp5327h Monitoring Catheter

FDA UDI

Class II (US FDA UDI)

by Argon Critical Care Systems Singapore Pte. Ltd.

Identity

Trade Name
CRITICATH(TM) SP5327H MONITORING CATHETER FDA UDI
Generic Name
Pulmonary artery balloon catheter, non-electrical FDA UDI
Device Name
Catheter 7FR, 2 Lumen, length 110 cm FDA UDI
Model / Reference
680058 FDA UDI
Description
Catheter 7FR, 2 Lumen, length 110 cm FDA UDI

Identifiers

Catalog Number
680058 FDA UDI
Primary DI / UDI-DI
00886333600588 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) Sp5327h 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Argon Critical Care Systems Singapore Pte. Ltd.

Sources (1)

  • FDA UDI 7f56f0e8-a654-41b8-9d55-fc0ec5265ef2 36 fields · synced Jun 1, 2026