Duns Number:079714011
Device Description: 24G Compatible PIVO Blood draw device
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
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
7afacdd4-5c6c-4148-9165-5bdb4f82b5de
Public Version Date
December 24, 2019
Public Version Number
1
DI Record Publish Date
December 16, 2019
Package DI Number
10850984007086
Quantity per Package
50
Contains DI Package
00850984007089
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |