Duns Number:106772781
Catalog Number
-
Brand Name
22G Open-System Ally Blood Collection Device
Version/Model Number
AV110000
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
52655fc5-2987-41d9-bf75-0b640ee7802d
Public Version Date
November 01, 2022
Public Version Number
1
DI Record Publish Date
October 24, 2022
Package DI Number
10850042365011
Quantity per Package
8
Contains DI Package
00850042365014
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack