Duns Number:023904428
Device Description: 500 mL USP Sterile Saline, Screw Top Container
Catalog Number
-
Brand Name
McKesson
Version/Model Number
37-6280
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 20, 2023
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
-
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
K083042,K083042
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
8e0fbf5c-745c-4bdd-b54b-20e55801642c
Public Version Date
February 21, 2022
Public Version Number
3
DI Record Publish Date
April 24, 2020
Package DI Number
40612479180305
Quantity per Package
18
Contains DI Package
10612479199580
Package Discontinue Date
July 20, 2023
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 |