Biowy Corporation

Address:27031 Vista Terrace,Lake Forest,CA,92630,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

Container, Frozen Donor Tissue Storage (LPZ) (4) Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (LJS) (2)

Premarket Exempt

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Biowy Freezing Bag - 00851739007002 Catalog Number :

Device Description : Biowy Freezing Bag FB50, Max Volume: 50 mL

Device Class :

Duns Number: 033858426

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Biowy Freezing Bag - 00851739007019 Catalog Number :

Device Description : Biowy Freezing Bag FB250, Max Volume: 250 mL

Device Class :

Duns Number: 033858426

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Biowy Freezing Bag - 00851739007026 Catalog Number :

Device Description : Biowy Freezing Bag FB500, Max Volume: 500 mL

Device Class : U

Duns Number: 033858426

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Biowy Freezing Bag - 00851739007033 Catalog Number :

Device Description : Biowy Freezing Bag FB1000, Max Volume: 1000 mL

Device Class : U

Duns Number: 033858426

Premarket Exempt : No

Product Code : LPZ

Prescription Use : Yes

Device Count : 1

Biowy PICC Catheter S Kit - 00851739007156 Catalog Number :

Device Description : PICC 4F Single Lumen Catheter S Kit

Device Class :

Duns Number: 033858426

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

Biowy PICC Catheter S Kit - 00851739007163 Catalog Number :

Device Description : PICC 5F Dual Lumen Catheter S Kit

Device Class :

Duns Number: 033858426

Premarket Exempt : No

Product Code : LJS

Prescription Use : Yes

Device Count : 1

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