Medline - METER, GLUCOSE. EVENCARE G2 - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: METER, GLUCOSE. EVENCARE G2

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More Product Details

Catalog Number

MPH1540NV

Brand Name

Medline

Version/Model Number

MPH1540NV

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NBW

Product Code Name

System, test, blood glucose, over the counter

Device Record Status

Public Device Record Key

8021b1e1-bb4b-4627-bc49-49494c02d2f8

Public Version Date

December 14, 2020

Public Version Number

1

DI Record Publish Date

December 04, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7