Duns Number:079714011
Device Description: PIVO 22G Compatible device
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
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
JKA
Product Code Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
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
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
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 3 |