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Conmed

FDA UDI

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name
CONMED FDA UDI
Generic Name
Electrocardiographic lead switching adaptor FDA UDI
Device Name
Adapter: Backpad - R Series Adapter FDA UDI
Model / Reference
38-620-R FDA UDI
Description
Adapter: Backpad - R Series Adapter FDA UDI

Identifiers

Catalog Number
38-620-R FDA UDI
Primary DI / UDI-DI
20653405006814 FDA UDI
510(k) Number
K761301 FDA UDI
FDA Product Code
DRX FDA UDI
GMDN Term
Electrocardiographic lead switching adaptor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2360 FDA UDI
Commercial Distribution
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

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

Yes

FDA UDI

Category: Electrocardiographic lead switching adaptor

Conmed by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead switching adaptor.

Cleared under the same submission

K761301 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Conmed Corporation

Sources (1)

  • FDA UDI 098b96af-0538-4d85-acba-4760b62623be 37 fields · synced May 30, 2026