DEVICE: M Zn-Air Battery Pak (07630016880445)

Device Identifier (DI) Information

M Zn-Air Battery Pak
CI-5501-240
Not in Commercial Distribution

Advanced Bionics AG
07630016880445
GS1
March 15, 2024
1
485262658 *Terms of Use
Resin Beige
CLOSE

Device Characteristics

MR Unsafe
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58185 Cochlear implant/auditory brainstem implant battery
An external component of a cochlear implant (CI) or auditory brainstem implant system designed to supply direct current (DC) to operate the electrically-powered and dependent components of the system. It is typically worn behind-the-ear (BTE), or is neck- or waist-worn, and may include an on/off switch. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MCM Implant, Cochlear
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P960058 149
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 55 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

f70edb6c-ac1b-4b2a-9eb1-b903bd8d32f8
March 18, 2024
3
February 09, 2021
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(661)362-1400
xxx@xxx.xxx
CLOSE