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Kendall

FDA UDI

Class II (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Kendall FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, single-use FDA UDI
Device Name
3000 Isolation Chamber,Rectal FDA UDI
Model / Reference
MI00325 FDA UDI
Description
3000 Isolation Chamber,Rectal FDA UDI

Identifiers

Catalog Number
MI00325 FDA UDI
Primary DI / UDI-DI
90884521148136 FDA UDI
FDA Product Code
GXY FDA UDI
GMDN Term
Transcutaneous electrical stimulation electrode, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1320 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

No

FDA UDI

Over-the-Counter

Yes

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: Transcutaneous electrical stimulation electrode, single-use

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

Similar devices

Also classified as Transcutaneous electrical stimulation electrode, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI 8d6a284a-8ecb-4b44-aeea-5e52e1b02086 36 fields · synced May 30, 2026