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OPTI Analyzer CCA TS

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref GD7013Model OPTI CRITICAL CARE ANALYZER - TS (TOUCHSCREEN)

by Opti Medical Systems Inc.

Identity

Trade Name
OPTI CCA -TS Blood Gas Analyzer EUDAMED
OPTI Analyzer CCA TS FDA UDI
Generic Name
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI
Device Name
OPTI CCA- TS EUDAMED
OPTI Analyzer CCA TS FDA UDI
Model / Reference
OPTI CRITICAL CARE ANALYZER - TS (TOUCHSCREEN) EUDAMED
GD7013 EUDAMED
1 FDA UDI
Description
OPTI Analyzer CCA TS FDA UDI

Identifiers

Catalog Number
GD7013 FDA UDI
Primary DI / UDI-DI
00894472000152 EUDAMEDFDA UDI
Basic UDI-DI
00894472GD70133M EUDAMED
Direct Marketing DI
00894472000152 EUDAMED
510(k) Number
K093280 FDA UDI
FDA Product Code
CHL FDA UDI
EMDN Code
W0201040101 BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes) EUDAMED
GMDN Term
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated FDA UDI

Classification

Device Class
Class A EUDAMED
Class II FDA UDI
Regulation Number
862.1120 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Metabolic profile clinical chemistry analyser IVD, portable, semi-automated

OPTI Analyzer CCA TS by Opti Medical Systems Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Metabolic profile clinical chemistry analyser IVD, portable, semi-automated.

Cleared under the same submission

K093280 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Opti Medical Systems Inc.

Sources (2)

  • FDA UDI 9e4d948f-cb3e-423d-9d06-c0c08cb34365 35 fields · synced Jun 19, 2026
  • EUDAMED ae8c5c07-e5b9-47c2-aa1c-b7790cd2e637 61 fields · synced Jun 19, 2026