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MediChoice

FDA UDI

Class II (US FDA UDI)

by Owens & Minor Distribution, Inc.

Identity

Trade Name
MediChoice FDA UDI
Generic Name
Electrocardiographic lead set, single-use FDA UDI
Device Name
6 Lead Set Disposable 0.9M PVC PA66 Cream 10ea per box with 20 boxes per case GE ApexPro FH Comp Direct Connect Not made with natural rubber latex MediChoice FDA UDI
Model / Reference
DCL40004 FDA UDI
Description
6 Lead Set Disposable 0.9M PVC PA66 Cream 10ea per box with 20 boxes per case GE ApexPro FH Comp Direct Connect Not made with natural rubber latex MediChoice FDA UDI

Identifiers

Primary DI / UDI-DI
10885632349676 FDA UDI
FDA Product Code
DSA FDA UDI
GMDN Term
Electrocardiographic lead set, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2900 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

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrocardiographic lead set, single-use

MediChoice by Owens & Minor Distribution, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead set, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Owens & Minor Distribution, Inc.

Sources (1)

  • FDA UDI 2e995d3e-b473-47e8-9e8f-c33d02692d0d 34 fields · synced Jun 8, 2026