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Comp Ta1019m-1 Dome

FDA UDI

Class II (US FDA UDI)

by Argon Critical Care Systems Singapore Pte. Ltd.

Identity

Trade Name
COMP TA1019M-1 DOME FDA UDI
Generic Name
Pressure transducer dome, single-use FDA UDI
Device Name
Critiflo Dome at 45 degree on a mounting plate FDA UDI
Model / Reference
682212 FDA UDI
Description
Critiflo Dome at 45 degree on a mounting plate FDA UDI

Identifiers

Catalog Number
682212 FDA UDI
Primary DI / UDI-DI
00886333622122 FDA UDI
FDA Product Code
DXO FDA UDI
GMDN Term
Pressure transducer dome, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2870 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: Pressure transducer dome, single-use

Comp Ta1019m-1 Dome 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 Pressure transducer dome, 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 38c26277-1c8d-485c-8c33-0d0feae59f19 35 fields · synced May 31, 2026