Duns Number:849626338
Device Description: SENSOR MMT-7008B ENLITE PLUS 2L 1CL PR
Catalog Number
-
Brand Name
Enlite™ Sensor
Version/Model Number
MMT-7008B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
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
c5c2c5ab-8d5a-46ce-96ec-c39fdfdb796b
Public Version Date
October 11, 2022
Public Version Number
6
DI Record Publish Date
September 09, 2016
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 |