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Battery

EUDAMEDFDA UDI

Class I (EU MDR)

Ref P07168-25Model BATTERY PACK ASSEMBLY, 6 CELL, LITHIUM-ION, M-TURBO

by Fujifilm Sonosite, Inc.

Identity

Trade Name
Battery EUDAMEDFDA UDI
Generic Name
Portable/mobile rechargeable battery pack FDA UDI
Device Name
BATTERY PACK ASSEMBLY, 6 CELL, LITHIUM-ION, M-TURBO EUDAMED
Diagnostic Ultrasound System Accessory. Battery mounted internally within an ultrasound system. FDA UDI
Model / Reference
BATTERY PACK ASSEMBLY, 6 CELL, LITHIUM-ION, M-TURBO EUDAMED
P07168-25 EUDAMEDFDA UDI
Description
Diagnostic Ultrasound System Accessory. Battery mounted internally within an ultrasound system. FDA UDI

Identifiers

Catalog Number
P07168 FDA UDI
Primary DI / UDI-DI
00841517106010 EUDAMEDFDA UDI
Basic UDI-DI
B-00841517106010 EUDAMED
510(k) Number
K071134 FDA UDI
K082098 FDA UDI
K101757 FDA UDI
K130173 FDA UDI
FDA Product Code
IYO FDA UDI
IYN FDA UDI
ITX FDA UDI
EMDN Code
Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
GMDN Term
Portable/mobile rechargeable battery pack FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
892.1550 FDA UDI
892.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Battery by Fujifilm Sonosite, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fujifilm Sonosite, Inc.
EUDAMED SRN
US-MF-000001075
Authorised Representative
Fujifilm Sonosite B.V. NL-AR-000000046

Sources (2)

  • EUDAMED 3062bbdd-10a0-4ad1-bf4f-d032b966cbed 61 fields · synced May 30, 2026
  • FDA UDI ab6b221c-0277-4e4d-901c-e1a8cd4872b2 36 fields · synced May 30, 2026