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

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 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd)Arterial blood sampler with 23Gx16mm needle, with needle shield device (nsd) and vented TIPCAP, 1.5 mL

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 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd)Arterial blood sampler with 25Gx16mm needle, with needle shield device (nsd) and vented TIPCAP, 1.5 mL.

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 Kit of QC material for the validation of sensor linear response in ABL90, ABL80 COOX, ABL80 COOX OSM series

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 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd) Arterial blood sampler with 23Gx16mm needle, with needle shield device (nsd) and vented TIPCAP, 1.5 mL, box of 100 pcs.

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 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd)Arterial blood sampler with 25Gx16mm needle, with needle shield device (nsd) and vented TIPCAP, 1.5 mL, box of 100 pcs.

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 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 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 safePICO 25Gx16mm (nsd)Arterial blood sampler with 25Gx16mm needle, with needle shield device (nsd) and vented TIPCAP, 1.5 mL, box of 100 pcs.

Device Class : 2

Duns Number: 086661485

Premarket Exempt : No

Product Code : JKA, MEG

Prescription Use : Yes

Device Count : 1

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