RADIOMETER AMERICA INC.

RADIOMETER AMERICA INC.

Address:810 SHARON DR.,WESTLAKE,OH,44145,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

Syringe, Antistick (MEG) (6) Tubes, Vials, Systems, Serum Separators, Blood Collection (JKA) (6) Controls For Blood-Gases, (Assayed And Unassayed) (JJS) (3) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1)

Premarket Exempt

No

Clear

Safe PICO Kit - 00860003561904 Catalog Number :

Device Description : 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with guss

Device Class : 2

Duns Number: 086661485

Premarket Exempt : No

Product Code : JKA, MEG

Prescription Use : Yes

Device Count : 1

safePICO - 00860003561928 Catalog Number :

Device Description : 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with guss

Device Class : 2

Duns Number: 086661485

Premarket Exempt : No

Product Code : JKA, MEG

Prescription Use : Yes

Device Count : 1

VK-3 - 00860003561935 Catalog Number :

Device Description : Kit of QC material for the validation of sensor linear response in ABL80 Flex series

Device Class : 1

Duns Number: 086661485

Premarket Exempt : No

Product Code : JJS

Prescription Use : Yes

Device Count : 1

VKR-5 - 00860003561942 Catalog Number :

Device Description : Kit of QC material for the validation of sensor linear response in ABL90, ABL80

Device Class : 1

Duns Number: 086661485

Premarket Exempt : No

Product Code : JJS

Prescription Use : Yes

Device Count : 1

VKR-7 - 00860003561959 Catalog Number :

Device Description : Kit of QC material for the validation of sensor linear response in ABL800 series

Device Class : 1

Duns Number: 086661485

Premarket Exempt : No

Product Code : JJS

Prescription Use : Yes

Device Count : 1

VK-CREA - 00860003561966 Catalog Number :

Device Description : Kit of QC material for the validation of sensor linear response in ABL8X7 series

Device Class : 1

Duns Number: 086661485

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

safePICO - 01860003561903 Catalog Number :

Device Description : 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with guss

Device Class : 2

Duns Number: 086661485

Premarket Exempt : No

Product Code : JKA, MEG

Prescription Use : Yes

Device Count : 1

safePICO - 01860003561927 Catalog Number :

Device Description : 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with guss

Device Class : 2

Duns Number: 086661485

Premarket Exempt : No

Product Code : JKA, MEG

Prescription Use : Yes

Device Count : 1

Safe PICO Kit - 10860003561901 Catalog Number :

Device Description : 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with guss

Device Class : 2

Duns Number: 086661485

Premarket Exempt : No

Product Code : JKA, MEG

Prescription Use : Yes

Device Count : 1

Safe PICO Kit - 10860003561925 Catalog Number :

Device Description : 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with guss

Device Class : 2

Duns Number: 086661485

Premarket Exempt : No

Product Code : JKA, MEG

Prescription Use : Yes

Device Count : 1

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