O'well

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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

Lancet, Blood (FMK) (9) System, Test, Blood Glucose, Over The Counter (NBW) (1)

Premarket Exempt

No Yes

Clear

owell - 00850015109003 Catalog Number :

Device Class : 2

Duns Number: 052943257

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

owell - 00850015109010 Catalog Number :

Device Class : 2

Duns Number: 052943257

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

owell - 00850015109027 Catalog Number :

Device Class : 2

Duns Number: 052943257

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

owell - 00850015109034 Catalog Number :

Device Class : 2

Duns Number: 052943257

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

Owell - 00860167002503 Catalog Number :

Device Description : Blood Glucose Testing Kit with 50 Refills

Device Class : 2

Duns Number: 052943257

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

owell - 00860167002510 Catalog Number :

Device Class : 2

Duns Number: 052943257

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

owell - 00860167002527 Catalog Number :

Device Class : 2

Duns Number: 052943257

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

owell - 00860167002534 Catalog Number :

Device Class : 2

Duns Number: 052943257

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

owell - 00860167002541 Catalog Number :

Device Class : 2

Duns Number: 052943257

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

owell - 00860167002558 Catalog Number :

Device Class : 2

Duns Number: 052943257

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

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