CLINICAL INNOVATIONS, LLC

Address:747 W 4170 S,MURRAY,UT,84123,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

Transducer, Pressure, Intrauterine (HFN) (10)

Premarket Exempt

No Yes

Clear

Koala® - 00814247020178 Catalog Number :

Device Description : Koala® Intrauterine Pressure Catheter with external balloon

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFN

Prescription Use : Yes

Device Count : 1

Koala® Cables - 00814247020192 Catalog Number :

Device Description : Cables to IUP catheters: HP8040A 5mV/1350

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFN

Prescription Use : Yes

Device Count : 1

Koala® Cables - 00814247020208 Catalog Number :

Device Description : Cables to IUP catheters: GE Coro 115/116/118

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFN

Prescription Use : Yes

Device Count : 1

Koala® Cables - 00814247020215 Catalog Number :

Device Description : Cables to IUP catheters: Litton Air-Shields Fetascan 1400

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFN

Prescription Use : Yes

Device Count : 1

Koala® Cables - 00814247020222 Catalog Number :

Device Description : Cables to IUP catheters: HP8040A 40mV

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFN

Prescription Use : Yes

Device Count : 1

Koala® Cables - 00814247020239 Catalog Number :

Device Description : Cables to IUP catheters: Space Labs Medical 94000

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFN

Prescription Use : Yes

Device Count : 1

Koala® Cables - 00814247020246 Catalog Number :

Device Description : Cables to IUP catheters: Neoventa

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFN

Prescription Use : Yes

Device Count : 1

Koala® Cables - 00814247020253 Catalog Number :

Device Description : Cables to IUP catheters

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFN

Prescription Use : Yes

Device Count : 1

Koala® Cables - 00814247020260 Catalog Number :

Device Description : Cables to IUP catheters: Philips Avalon

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFN

Prescription Use : Yes

Device Count : 1

Koala® Cables - 00814247020277 Catalog Number :

Device Description : Cables to IUP catheters: Edan F6

Device Class : 2

Duns Number: 809524291

Premarket Exempt : No

Product Code : HFN

Prescription Use : Yes

Device Count : 1

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