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Therapak

FDA UDI

Class I (US FDA UDI)

by Therapak LLC

Identity

Trade Name
Therapak FDA UDI
Generic Name
Blood/tissue storage/culture container FDA UDI
Device Name
2 Litre Histology Container (CS/20) FDA UDI
Model / Reference
ACSK75098 FDA UDI
Description
2 Litre Histology Container (CS/20) FDA UDI

Identifiers

Catalog Number
ACSK75098 FDA UDI
Primary DI / UDI-DI
00810185250608 FDA UDI
FDA Product Code
NNK FDA UDI
GMDN Term
Blood/tissue storage/culture container FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Blood/tissue storage/culture container

Therapak by Therapak LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood/tissue storage/culture container.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Therapak LLC

Sources (1)

  • FDA UDI 1d8bc828-c992-4487-a54a-841e68934852 34 fields · synced Jun 1, 2026