Model: MMT-8062
DI: 00763000848149
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
PUMP MMT-8062 FLEX US REPL
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0d15b247-8dab-45cd-a240-d233dc3384a1
Distribution Status:
In Commercial Distribution
DUNS Number:
849626338
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
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:
00763000848149
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64891
Name: Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Definition:
A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on a continuous scalar algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system.
FDA Product Codes
QFG
Alternate controller enabled insulin infusion pump
Premarket Submissions
Submission Number:
K253743
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling Low - @attributes - Value:
25
Item #1 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling High - @attributes - Value:
90
Item #1 - Storage Handling Type:
Storage Environment Humidity
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
-20
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
50
Item #2 - Storage Handling Type:
Storage Environment Temperature