Catalog Number

-

Brand Name

20G Open-System Ally Blood Collection Device

Version/Model Number

AV100000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K220258,K220258,K220258

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Public Device Record Key

80eb8b2f-f89a-446b-b111-a8d1f8e3e584

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Package DI Number

10850042365004

Quantity per Package

8

Contains DI Package

00850042365007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack