Genemed®

FDA UDI

Class I (US FDA UDI)

by Sakura Finetek USA, Inc

Identity

Trade Name: Genemed® FDA UDI
Generic Name: pH-adjusted buffer solution IVD FDA UDI
Device Name: TBST (Tris Buffered Saline and 0.05% Tween 20), pH 7.4 (20X), Concentrate, 100 mL FDA UDI
Model / Reference: 10-0028 FDA UDI
Description: TBST (Tris Buffered Saline and 0.05% Tween 20), pH 7.4 (20X), Concentrate, 100 mL FDA UDI

Identifiers

Catalog Number: 10-0028 FDA UDI
Primary DI / UDI-DI: 00615233007018 FDA UDI
FDA Product Code: PPM FDA UDI
GMDN Term: pH-adjusted buffer solution IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.4010 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: pH-adjusted buffer solution IVD

Genemed® by Sakura Finetek USA, Inc — 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: Sakura Finetek USA, Inc

Sources (1)

FDA UDI 21f3339d-0b3d-4c7c-821f-2f4a88aca521 35 fields · synced May 29, 2026