De Soutter Medical

FDA UDI

Class I (US FDA UDI)

by De Soutter Medical, Ltd.

Identity

Trade Name: De Soutter Medical FDA UDI
Generic Name: Portable/mobile rechargeable battery pack FDA UDI
Device Name: AB-701 BATTERY - ASEPTIC Ni-MH 10.8v FDA UDI
Model / Reference: 15340 FDA UDI
Description: AB-701 BATTERY - ASEPTIC Ni-MH 10.8v FDA UDI

Identifiers

Catalog Number: 15340 FDA UDI
Primary DI / UDI-DI: 05051471122680 FDA UDI
FDA Product Code: GEY FDA UDI
GMDN Term: Portable/mobile rechargeable battery pack FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Portable/mobile rechargeable battery pack

De Soutter Medical by De Soutter Medical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: De Soutter Medical, Ltd.

Sources (1)

FDA UDI ffa95836-7168-44d5-817d-b15ed19dc7ea 34 fields · synced May 29, 2026