Duns Number:849626338
Device Description: XMTR MMT-7735NA ENLT V1.3 RPL EN MNM1
Catalog Number
-
Brand Name
MiniLink®
Version/Model Number
MMT-7735NA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 15, 2016
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P120010
Product Code
OZO
Product Code Name
Artificial pancreas device system, threshold suspend
Public Device Record Key
a78ccd89-b944-4965-869b-05011e643e07
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |
| 3 | A medical device with high risk that requires premarket approval | 1084 |