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Devon

FDA UDI

Class II (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Devon FDA UDI
Generic Name
Medical equipment handle cover, single-use, non-sterile FDA UDI
Device Name
3600-39 ULH FOR ADMECO X1 FDA UDI
Model / Reference
50001204 FDA UDI
Description
3600-39 ULH FOR ADMECO X1 FDA UDI

Identifiers

Catalog Number
50001204 FDA UDI
Primary DI / UDI-DI
10884521548084 FDA UDI
510(k) Number
K142386 FDA UDI
FDA Product Code
FTA FDA UDI
GMDN Term
Medical equipment handle cover, single-use, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4580 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical equipment handle cover, single-use, non-sterile

Devon by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment handle cover, single-use, non-sterile.

Cleared under the same submission

K142386 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI 0aa070b1-3842-4c07-a520-4ceabc0ac591 37 fields · synced May 29, 2026