Medline - ANEROID,HAND HELD,NYLON CS,ROYAL BLUE - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: ANEROID,HAND HELD,NYLON CS,ROYAL BLUE

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More Product Details

Catalog Number

MDS9114

Brand Name

Medline

Version/Model Number

MDS9114

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

DXN

Product Code Name

System, measurement, blood-pressure, non-invasive

Device Record Status

Public Device Record Key

001a23ea-a08f-4486-b10c-968534818f92

Public Version Date

October 16, 2020

Public Version Number

1

DI Record Publish Date

October 08, 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