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Corning

FDA UDI

Class I (US FDA UDI)

by Corning Incorporated

Identity

Trade Name
Corning FDA UDI
Generic Name
Blood/tissue storage/culture container FDA UDI
Device Name
Corning 250 ml ERL, ATC w/Sample Port, Sterile, 1 per bag, 4 per case FDA UDI
Model / Reference
11813 FDA UDI
Description
Corning 250 ml ERL, ATC w/Sample Port, Sterile, 1 per bag, 4 per case FDA UDI

Identifiers

Catalog Number
11813 FDA UDI
Primary DI / UDI-DI
H108118131 FDA UDI
FDA Product Code
KJA 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
Not 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

No

FDA UDI

Corning by Corning Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI f0c9c0c8-a4d0-4e21-ad31-bf7f1fb89f1f 36 fields · synced May 31, 2026