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Cardinal Health

FDA UDI

Class I (US FDA UDI)

by Aero-Med Llc

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Urine specimen collection kit IVD FDA UDI
Device Name
Urine Transfer Kit, Contains Urine Transfer Device and 9mL UA Conical Tube No Additive FDA UDI
Model / Reference
CHBUTK3 FDA UDI
Description
Urine Transfer Kit, Contains Urine Transfer Device and 9mL UA Conical Tube No Additive FDA UDI

Identifiers

Catalog Number
CHBUTK3 FDA UDI
Primary DI / UDI-DI
10885380169434 FDA UDI
FDA Product Code
OIB FDA UDI
GMDN Term
Urine specimen collection kit IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Convenience Kit

Yes

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

Cardinal Health by Aero-Med Llc — 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

Manufacturer
Aero-Med Llc

Sources (1)

  • FDA UDI 25292b9c-6660-4d64-843b-97a8ff0f9c13 36 fields · synced May 30, 2026