PIVO 24G - 24G Compatible PIVO Blood draw device - VELANO VASCULAR, INC.

Duns Number:079714011

Device Description: 24G Compatible PIVO Blood draw device

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More Product Details

Catalog Number

202-0011

Brand Name

PIVO 24G

Version/Model Number

202-0011

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

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Device Record Status

Public Device Record Key

7afacdd4-5c6c-4148-9165-5bdb4f82b5de

Public Version Date

December 24, 2019

Public Version Number

1

DI Record Publish Date

December 16, 2019

Additional Identifiers

Package DI Number

10850984007086

Quantity per Package

50

Contains DI Package

00850984007089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"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