Duns Number:597723837
Device Description: DonorCare® Needle Guard is intended to aid in the prevention of accidental needle stick in DonorCare® Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures.
Catalog Number
A100150
Brand Name
DonorCare® Needle Guard Large Channel
Version/Model Number
A100150
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"
-
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
BK980008,BK980008
Product Code
KSS
Product Code Name
Supplies, Blood-Bank
Public Device Record Key
4a855c84-4c36-4e63-a8d7-debee7e9ce8a
Public Version Date
September 28, 2020
Public Version Number
1
DI Record Publish Date
September 20, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |