Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: Medline FDA UDI
Generic Name: Electrocardiographic electrode, single-use FDA UDI
Device Name: ELECTRODE,NEONATE,RADIOTRANS,LIMB BAND FDA UDI
Model / Reference: MDSM611LIMB FDA UDI
Description: ELECTRODE,NEONATE,RADIOTRANS,LIMB BAND FDA UDI

Identifiers

Catalog Number: MDSM611LIMB FDA UDI
Primary DI / UDI-DI: 10888277688452 FDA UDI
510(k) Number: K053011 FDA UDI
FDA Product Code: DRX FDA UDI
GMDN Term: Electrocardiographic electrode, single-use 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrocardiographic electrode, single-use

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Electrocardiographic electrode, single-use.

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SWAROMED — TYROLMED GmbH · Class II
SWAROMED — TYROLMED GmbH · Class II
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Cleared under the same submission

K053011 also covers:

Vyaire — Airlife, Inc.
Vyaire — Airlife, Inc.
CareFusion — BIOPROTECH INC.
CareFusion — BIOPROTECH INC.
CARDINAL HEALTH — Cardinal Health 200, LLC
MediMax Tech — MEDIMAX TECH INC.
MediMax Tech — MEDIMAX TECH INC.
MediMax Tech — MEDIMAX TECH INC.
MediMax Tech — MEDIMAX TECH INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medline Industries, Inc.

Sources (1)

FDA UDI ffe5ef19-f69f-48d2-b4a0-c0b29210d266 36 fields · synced May 30, 2026