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M Zn-Air Battery Pak

FDA UDI

Class III (US FDA UDI)

by Advanced Bionics

Identity

Trade Name
M Zn-Air Battery Pak FDA UDI
Generic Name
Cochlear implant/auditory brainstem implant battery FDA UDI
Device Name
Lava Red FDA UDI
Model / Reference
CI-5501-280 FDA UDI
Description
Lava Red FDA UDI

Identifiers

Primary DI / UDI-DI
07630016880346 FDA UDI
PMA Number
P960058 FDA UDI
FDA Product Code
MCM FDA UDI
GMDN Term
Cochlear implant/auditory brainstem implant battery FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

The M Zn-Air Battery Pak is a reusable, behind-the-ear (BTE) cochlear implant/auditory brainstem implant battery designed to provide direct current (DC) power to operate the system. This device is typically worn for life and features advanced safety features such as MR Safety certification.

Cleared under the same submission

P960058 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Bionics

Sources (1)

  • FDA UDI 7446937d-48ac-46eb-a060-d01b6b591b89 37 fields · synced Jul 31, 2026