Curaplex - IV Catheter, ClearSafe, 14 ga x 1 1/4 in, Safety - BOUND TREE MEDICAL, LLC

Duns Number:070556204

Device Description: IV Catheter, ClearSafe, 14 ga x 1 1/4 in, Safety 50ea/bx 4bx/cs

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More Product Details

Catalog Number

-

Brand Name

Curaplex

Version/Model Number

1612-84110

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

FOZ

Product Code Name

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

Device Record Status

Public Device Record Key

38430343-9b8e-4b7f-8b20-aee4d4c1dc4a

Public Version Date

November 02, 2020

Public Version Number

4

DI Record Publish Date

December 14, 2016

Additional Identifiers

Package DI Number

00815277023368

Quantity per Package

50

Contains DI Package

00815277023351

Package Discontinue Date

-

Package Status

In Commercial Distribution

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