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Gabarith™ Pmset 1dt-Xx

FDA UDI

Class II (US FDA UDI)

by Argon Critical Care Systems Singapore Pte. Ltd.

Identity

Trade Name
GABARITH™ PMSET 1DT-XX FDA UDI
Generic Name
Invasive-pressure external transducer, single-use FDA UDI
Device Name
60 drops, 60" tube length AdSet connected to a 3cc transducer. The patient line includes a 50" Pressure Tubing, 4-way in-line stopcock and a 10" Pressure Tubing. It includes a separately packed 50" Pressure tube connects with a 4-way stopcock. A separately packed 3x male, 1x female protective caps and a colour label set. FDA UDI
Model / Reference
682017 FDA UDI
Description
60 drops, 60" tube length AdSet connected to a 3cc transducer. The patient line includes a 50" Pressure Tubing, 4-way in-line stopcock and a 10" Pressure Tubing. It includes a separately packed 50" Pressure tube connects with a 4-way stopcock. A separately packed 3x male, 1x female protective caps and a colour label set. FDA UDI

Identifiers

Catalog Number
682017 FDA UDI
Primary DI / UDI-DI
00886333620173 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Invasive-pressure external transducer, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 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

Gabarith™ Pmset 1dt-Xx 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 a30668fe-b320-4701-a2da-45d41c6c3194 36 fields · synced May 30, 2026