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Biowy Freezing Bag

FDA UDI

Class U (US FDA UDI)

by Biowy Corporation

Identity

Trade Name
Biowy Freezing Bag FDA UDI
Generic Name
Blood/tissue storage/culture container FDA UDI
Device Name
Biowy Freezing Bag FB500, Max Volume: 500 mL FDA UDI
Model / Reference
FB500 FDA UDI
Description
Biowy Freezing Bag FB500, Max Volume: 500 mL FDA UDI

Identifiers

Primary DI / UDI-DI
00851739007026 FDA UDI
FDA Product Code
LPZ FDA UDI
GMDN Term
Blood/tissue storage/culture container FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Blood/tissue storage/culture container

Biowy Freezing Bag by Biowy Corporation — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood/tissue storage/culture container.

Cleared under the same submission

BK170150 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biowy Corporation

Sources (1)

  • FDA UDI ee080f07-b7e8-4e38-a9ec-1cce891e2955 35 fields · synced May 30, 2026