PIVO 22G - PIVO 22G Compatible device - VELANO VASCULAR, INC.

Duns Number:079714011

Device Description: PIVO 22G Compatible device

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More Product Details

Catalog Number

-

Brand Name

PIVO 22G

Version/Model Number

000-0011

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2018

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

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Device Record Status

Public Device Record Key

959633f8-c160-4cc0-a9f5-cd606c716039

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

January 03, 2017

Additional Identifiers

Package DI Number

10850984007017

Quantity per Package

50

Contains DI Package

00850984007010

Package Discontinue Date

July 01, 2018

Package Status

Not in Commercial Distribution

Package Type

-

"VELANO VASCULAR, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3