Clinical Guard

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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

Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (4) Oximeter, Infrared, Sporting, Aviation (OCH) (2) Test, Luteinizing Hormone (Lh), Over The Counter (NGE) (2) Monitor, Ultrasonic, Fetal (KNG) (1)

Premarket Exempt

No Yes

Clear

Clinical Guard - 00897429002513 Catalog Number :

Device Class :

Duns Number: 827033924

Premarket Exempt : No

Product Code : KNG

Prescription Use : Yes

Device Count : 1

Clinical Guard - 00897429002520 Catalog Number :

Device Class : 2

Duns Number: 827033924

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

Clinical Guard - 00897429002704 Catalog Number :

Device Class :

Duns Number: 827033924

Premarket Exempt : No

Product Code : NGE, LCX

Prescription Use : No

Device Count : 50

Clinical Guard - 00897429002766 Catalog Number :

Device Class :

Duns Number: 827033924

Premarket Exempt : Yes

Product Code : NGE

Prescription Use : No

Device Count : 50

Clinical Guard - 00897429002834 Catalog Number :

Device Class :

Duns Number: 827033924

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 50

Clinical Guard - 00897429002841 Catalog Number :

Device Class :

Duns Number: 827033924

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 25

Clinical Guard - 00897429002858 Catalog Number :

Device Class :

Duns Number: 827033924

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 20

Clinical Guard - 00897429002971 Catalog Number :

Device Class : 2

Duns Number: 827033924

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

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