Curaplex - Curaplex 3 BP Kit, Blue - BOUND TREE MEDICAL, LLC

Duns Number:070556204

Device Description: Curaplex 3 BP Kit, Blue

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More Product Details

Catalog Number

533-MS-MED3N

Brand Name

Curaplex

Version/Model Number

533-MS-MED3N

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"

-

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

DXQ

Product Code Name

blood pressure cuff

Device Record Status

Public Device Record Key

c8a331d1-ab92-43d2-a144-575d0a9b51af

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 22, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BOUND TREE MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 471
2 A medical device with a moderate to high risk that requires special controls. 540
3 A medical device with high risk that requires premarket approval 3
U Unclassified 1