Curaplex - Curaplex IV Start Kit - BOUND TREE MEDICAL, LLC

Duns Number:070556204

Device Description: Curaplex IV Start Kit

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More Product Details

Catalog Number

670067-KIT

Brand Name

Curaplex

Version/Model Number

670067-KIT

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)

Yes

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

-

Product Code Details

Product Code

FOZ

Product Code Name

Catheter,intravascular,therapeutic,short-term less than 30 days

Device Record Status

Public Device Record Key

467af081-55e4-4f97-8361-5209ecad4eb9

Public Version Date

August 16, 2022

Public Version Number

4

DI Record Publish Date

December 14, 2016

Additional Identifiers

Package DI Number

00810094570743

Quantity per Package

50

Contains DI Package

00815277021593

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"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