Medline - CUFF, BP, REUSE, 2T, LRG AD, BV - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: CUFF, BP, REUSE, 2T, LRG AD, BV

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More Product Details

Catalog Number

MDS9914BVRE

Brand Name

Medline

Version/Model Number

MDS9914BVRE

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

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

-

Product Code Details

Product Code

DXQ

Product Code Name

blood pressure cuff

Device Record Status

Public Device Record Key

3abf9b08-e01f-4d45-b34b-35a9b66a2e79

Public Version Date

February 16, 2021

Public Version Number

1

DI Record Publish Date

February 08, 2021

Additional Identifiers

Package DI Number

20888277663364

Quantity per Package

5

Contains DI Package

10888277663367

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG

"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