Duns Number:023904428
Device Description: Syringe Irrigation Piston Flat Top w New Cathe Tip and IV Pole Bag
Catalog Number
-
Brand Name
Mckesson
Version/Model Number
910
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KYZ
Product Code Name
Syringe, Irrigating (Non Dental)
Public Device Record Key
f01136dc-57ef-4cc4-9387-e86c6ea7187c
Public Version Date
August 25, 2020
Public Version Number
1
DI Record Publish Date
August 17, 2020
Package DI Number
40612479201918
Quantity per Package
50
Contains DI Package
10612479201900
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 |