Bioseal Inc.

FDA UDI

Class I (US FDA UDI)

by Bioseal

Identity

Trade Name: Bioseal Inc. FDA UDI
Generic Name: Culture tube FDA UDI
Device Name: Specimen Tube FDA UDI
Model / Reference: 17370/100 FDA UDI
Description: Specimen Tube FDA UDI

Identifiers

Primary DI / UDI-DI: 00630094173702 FDA UDI
FDA Product Code: KJG FDA UDI
GMDN Term: Culture tube FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.3010 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Culture tube

Bioseal Inc. by Bioseal — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Bioseal

Sources (1)

FDA UDI 36da452a-dfd3-43a5-9e93-5886a3f79931 33 fields · synced Jun 6, 2026