Enlite™ Sensor - SENSOR MMT-7008B ENLITE PLUS 2L 1CL PR - MEDTRONIC MINIMED, INC.

Duns Number:849626338

Device Description: SENSOR MMT-7008B ENLITE PLUS 2L 1CL PR

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More Product Details

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

Product Characteristics

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 Details

Product Code

OZO

Product Code Name

Artificial pancreas device system, threshold suspend

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC MINIMED, INC." Characteristics
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