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

Tube, Aspirating, Flexible, Connecting (BYY) (5) Immunoassay For Detection Of Amniotic Fluid Protein(S). (NQM) (2) Support, Patient Position (CCX) (2)

Premarket Exempt

No Yes

Clear

ROM Plus, Complete Kit Fetal Membranes Rupture Test - 00814247020925 Catalog Number :

Device Description : ROM Plus POC Correlation Kit

Device Class : 1

Duns Number: 809524291

Premarket Exempt : No

Product Code : NQM

Prescription Use : Yes

Device Count : 1

ROM Plus, Complete Kit Fetal Membranes Rupture Test - 00814247020956 Catalog Number :

Device Description : ROM Plus Strip/Collection Kit

Device Class : 1

Duns Number: 809524291

Premarket Exempt : No

Product Code : NQM

Prescription Use : Yes

Device Count : 1

BoogieBaby nasal aspirator – flair tip with cover - 00814247021076 Catalog Number :

Device Description : BoogieBaby nasal aspirator – flair tip with cover

Device Class :

Duns Number: 809524291

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : Yes

Device Count : 1

BoogieBaby nasal aspirator – olive tip 4.5 inch long - 00814247021083 Catalog Number :

Device Description : BoogieBaby nasal aspirator – olive tip 4.5 inch long

Device Class :

Duns Number: 809524291

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : Yes

Device Count : 1

BoogieBaby nasal aspirator – olive tip 3.25 inch long - 00814247021090 Catalog Number :

Device Description : BoogieBaby nasal aspirator – olive tip 3.25 inch long

Device Class :

Duns Number: 809524291

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : Yes

Device Count : 1

BoogieBaby nasal aspirator – olive tip 4.5 inch with cover - 00814247021106 Catalog Number :

Device Description : BoogieBaby nasal aspirator – olive tip 4.5 inch with cover

Device Class :

Duns Number: 809524291

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : Yes

Device Count : 1

BoogieBaby nasal aspirator – olive tip 3.25 inch with cover - 00814247021113 Catalog Number :

Device Description : BoogieBaby nasal aspirator – olive tip 3.25 inch with cover

Device Class :

Duns Number: 809524291

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : Yes

Device Count : 1

traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetai - 30814247020346 Catalog Number :

Device Description : Traxi Panniculus Retractor with Retentus Technology (BMI 30-50)

Device Class :

Duns Number: 809524291

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : Yes

Device Count : 1

traxi® Panniculus Retractor Extender - 30814247020360 Catalog Number :

Device Description : Traxi Extender with Retentus Technology (BMI>50 - used with PH-25)

Device Class :

Duns Number: 809524291

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : Yes

Device Count : 1

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