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Kendall

FDA UDI

Class II (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Kendall FDA UDI
Generic Name
Electrocardiographic lead set, reusable FDA UDI
Device Name
Lead Wires;D-3A1120 DIN to Snap, White FDA UDI
Model / Reference
31244422A FDA UDI
Description
Lead Wires;D-3A1120 DIN to Snap, White FDA UDI

Identifiers

Catalog Number
31244422A FDA UDI
Primary DI / UDI-DI
20884521148397 FDA UDI
510(k) Number
K942321 FDA UDI
FDA Product Code
DSA FDA UDI
GMDN Term
Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2900 FDA UDI
Commercial Distribution
Not 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
MRI Safety
MR Unsafe FDA UDI

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

Cleared under the same submission

K942321 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 2c7c3a84-4161-49ba-811c-e52da2e8eeb0 38 fields · synced Jun 1, 2026