Stradis Medical, LLC. - IV START KIT - STRADIS MEDICAL LLC

Duns Number:043537671

Device Description: IV START KIT

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More Product Details

Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

IV-760

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

FPA

Product Code Name

Set, Administration, Intravascular

Device Record Status

Public Device Record Key

b9d64a55-e3f0-4625-8983-ffa05f57e6af

Public Version Date

May 07, 2021

Public Version Number

3

DI Record Publish Date

April 23, 2018

Additional Identifiers

Package DI Number

M765IV7605

Quantity per Package

50

Contains DI Package

M752IV7600

Package Discontinue Date

May 05, 2021

Package Status

Not in Commercial Distribution

Package Type

outer box

"STRADIS MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 38