Deltaven Fast Flash - Safety IV catheter in PUR with closed system, - DELTA MED SPA

Duns Number:444776777

Device Description: Safety IV catheter in PUR with closed system, double entry

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More Product Details

Catalog Number

-

Brand Name

Deltaven Fast Flash

Version/Model Number

3841573

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

b15ed5d4-9036-468a-8981-6c664de15eee

Public Version Date

November 03, 2020

Public Version Number

1

DI Record Publish Date

October 26, 2020

Additional Identifiers

Package DI Number

38032248005410

Quantity per Package

25

Contains DI Package

08032248005419

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"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