Wolf-Pak Self Safe Safety IV Catheter - IV safety catheter - DELTA MED SPA

Duns Number:444776777

Device Description: IV safety catheter

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More Product Details

Catalog Number

-

Brand Name

Wolf-Pak Self Safe Safety IV Catheter

Version/Model Number

3728760

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

6c32d736-5113-4447-b69f-f02dcd91e6ff

Public Version Date

January 28, 2020

Public Version Number

1

DI Record Publish Date

January 20, 2020

Additional Identifiers

Package DI Number

58032248372875

Quantity per Package

4

Contains DI Package

38032248372871

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"DELTA MED SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 105