OPTI MEDICAL SYSTEMS, INC.

Address:235 Hembree Park Dr,ROSWELL,GA,30076,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Arterial Blood Sampling Kit (CBT) (3) Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph (CHL) (2) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (2) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (1) Electrode, Ion Specific, Potassium (CEM) (1) System, Hemoglobin, Automated (GKR) (1)

Premarket Exempt

No Yes

Clear

OPTI Accessory Kit - 00894472000077 Catalog Number : GD7045

Device Description : OPTI CCA Analyzer accessory kit

Device Class : 1

Duns Number: 801458279

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

OPTI Check Control Tri Level - 00894472000107 Catalog Number : HC7008

Device Description : OPTI Check Controls Tri Level

Device Class : 1

Duns Number: 801458279

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

OPTI Check Plus - 00894472000114 Catalog Number : HC7009

Device Description : OPTI Check Plus Tri-level controls

Device Class : 1

Duns Number: 801458279

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Comfort Sampler - 00894472000138 Catalog Number : BP0600

Device Description : Comfort Sampler, Arterial Blood Sampler

Device Class : 1

Duns Number: 801458279

Premarket Exempt : Yes

Product Code : CBT

Prescription Use : Yes

Device Count : 1

OPTI CCA TS Accessory Kit - 00894472000145 Catalog Number : BP7035

Device Description : OPTI CCA TS Accessory Kit

Device Class : 2

Duns Number: 801458279

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

OPTI Analyzer CCA TS - 00894472000152 Catalog Number : GD7013

Device Description : OPTI Analyzer CCA TS

Device Class : 2

Duns Number: 801458279

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

Comfort Sampler, Basic Kit - 00894472000176 Catalog Number : BP0610

Device Description : Comfort Sampler, Basic Kit

Device Class : 1

Duns Number: 801458279

Premarket Exempt : Yes

Product Code : CBT

Prescription Use : Yes

Device Count : 1

Comfort Sampler Bulk - 00894472000183 Catalog Number : BP0620

Device Description : Bulk Comfort Sampler

Device Class : 1

Duns Number: 801458279

Premarket Exempt : Yes

Product Code : CBT

Prescription Use : Yes

Device Count : 1

B Cassette - 00894472000237 Catalog Number : BP7562

Device Description : B Cassette Carton

Device Class : 2

Duns Number: 801458279

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

OPTI CCA E Cassette - 00894472000244 Catalog Number : BP7587

Device Description : OPTI CCA E Cassette

Device Class : 2

Duns Number: 801458279

Premarket Exempt : No

Product Code : CEM

Prescription Use : Yes

Device Count : 1

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