Valleylab

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: Valleylab FDA UDI
Generic Name: Electrosurgical return electrode, single-use FDA UDI
Device Name: REM Polyhesive (TM) Infant Patient Return Electrode FDA UDI
Model / Reference: E7510-25 FDA UDI
Description: REM Polyhesive (TM) Infant Patient Return Electrode FDA UDI

Identifiers

Primary DI / UDI-DI: 10884524001043 FDA UDI
510(k) Number: K160290 FDA UDI
K822572 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Electrosurgical return electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 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

Dimensions & Sizes

Size: Length — 9 Feet FDA UDI

Category: Electrosurgical return electrode, single-use

Valleylab by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K160290 also covers:

Valleylab — Covidien LP

K822572 also covers:

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: Covidien LP

Sources (1)

FDA UDI d1de32fb-6bb6-451a-bd17-f7a5e94c1e52 37 fields · synced May 29, 2026