Duns Number:961027315
Device Description: STERILE PHLEBOTOMY KIT
Catalog Number
17D0460
Brand Name
CARDINAL HEALTH
Version/Model Number
17D0460
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
OFM
Product Code Name
Phlebotomy blood collection kit
Public Device Record Key
24b73272-3151-46ec-92ca-dc4e496ddfe4
Public Version Date
July 19, 2018
Public Version Number
3
DI Record Publish Date
December 06, 2016
Package DI Number
50887488629993
Quantity per Package
100
Contains DI Package
10887488629995
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |