TiMesh®

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name: TiMesh® FDA UDI
Generic Name: Disposable battery pack FDA UDI
Device Name: BATTERY 8004105 BPD 5-PACK FDA UDI
Model / Reference: 8004105 FDA UDI
Description: BATTERY 8004105 BPD 5-PACK FDA UDI

Identifiers

Primary DI / UDI-DI: 70721902805485 FDA UDI
510(k) Number: K062348 FDA UDI
FDA Product Code: HWC FDA UDI
HRS FDA UDI
GMDN Term: Disposable battery pack FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Disposable battery pack

TiMesh® by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Disposable battery pack.

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IQ SYSTEM — BIOMET MICROFIXATION, INC · Class I
AED Battery Exchange — AED Battery Exchange, LLC · Class III
Insurgical, Inc. — Insurgical, Inc. · Class I
Battery Pack, Single Use, PDCMF, Tadiran — PRO-DEX, INC. · Class I
LEVEL ONE, STERILE — KLS-Martin L.P. · Class I
Bioseal Inc. — BIOSEAL · Class I

Cleared under the same submission

K062348 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: Medtronic PS Medical

Sources (1)

FDA UDI b06976b3-665a-41ae-baa8-33a812986feb 35 fields · synced Jun 6, 2026