Overwrap Bag

FDA UDI

Class II (US FDA UDI)

by Biosafe S.A.

Identity

Trade Name: Overwrap Bag FDA UDI
Generic Name: Blood centrifugation system containment kit FDA UDI
Model / Reference: Overwrap Bag FDA UDI

Identifiers

Catalog Number: 4085 FDA UDI
Primary DI / UDI-DI: 07640125650518 FDA UDI
FDA Product Code: OAO FDA UDI
GMDN Term: Blood centrifugation system containment kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.9900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Blood centrifugation system containment kit

Overwrap Bag by Biosafe S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

BK090037 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biosafe S.A.

Sources (1)

FDA UDI 950812b0-6339-41a0-845c-359224c7f392 35 fields · synced Jun 1, 2026