Duns Number:023904428
Device Description: Blood Transfer Device Pink (200/bx, 4/cs)
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16- FBT01
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
K172763,K172763,K172763
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
35706a65-6ec0-4f39-9ca6-d1b4e3478a9f
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
July 14, 2020
Package DI Number
40612479258844
Quantity per Package
4
Contains DI Package
20612479258833
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |