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Venous Close Loop System

FDA UDI

Class II (US FDA UDI)

by Argon Critical Care Systems Singapore Pte. Ltd.

Identity

Trade Name
VENOUS CLOSE LOOP SYSTEM FDA UDI
Generic Name
Invasive-pressure external transducer, single-use FDA UDI
Device Name
Septum set connected with a 10cc syringe with touchguard stops at 10cc and a 60" Pressure tubing & a 3" small bore tube. FDA UDI
Model / Reference
688695 FDA UDI
Description
Septum set connected with a 10cc syringe with touchguard stops at 10cc and a 60" Pressure tubing & a 3" small bore tube. FDA UDI

Identifiers

Catalog Number
688695 FDA UDI
Primary DI / UDI-DI
00886333686957 FDA UDI
FDA Product Code
DSK FDA UDI
GMDN Term
Invasive-pressure external transducer, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1110 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: Invasive-pressure external transducer, single-use

Venous Close Loop System 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 Invasive-pressure external transducer, single-use.

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 bb494314-6f64-4d51-b1bf-d5e5cb2ed7a4 36 fields · synced Jun 1, 2026