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Exp-Pak

FDA UDI

Class I (US FDA UDI)

by Charter Medical, Llc

Identity

Trade Name
EXP-PAK FDA UDI
Generic Name
Blood/tissue storage/culture container FDA UDI
Device Name
EXP-Pak Cell Expansion Container 3L Capacity FDA UDI
Model / Reference
EXP-3L FDA UDI
Description
EXP-Pak Cell Expansion Container 3L Capacity FDA UDI

Identifiers

Catalog Number
EXP-3L FDA UDI
Primary DI / UDI-DI
00817827027024 FDA UDI
FDA Product Code
KJF FDA UDI
GMDN Term
Blood/tissue storage/culture container FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.2240 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Blood/tissue storage/culture container

Exp-Pak by Charter Medical, 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
Charter Medical, Llc

Sources (1)

  • FDA UDI 4b7f5fca-4c96-404d-8f46-3d1058a50999 35 fields · synced May 30, 2026