Model: TM90T0
DI: 00199150021277
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-02
Current Version: 2026-05-11
Description
COMMUNICATOR TM90T0 GCC US EMANUAL
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
065aab57-f887-4045-8ad1-a6878aec103e
Distribution Status:
In Commercial Distribution
DUNS Number:
006261481
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00199150021277
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61393
Name: Multiple active implantable device programmer
Definition:
An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.
FDA Product Codes
LKK
Pump, infusion, implanted, programmable
OUG
Medical device data system
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling Low - @attributes - Value:
-31
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling High - @attributes - Value:
136
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
-35
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
58
Item #2 - Storage Handling Type:
Storage Environment Temperature