Duns Number:023904428
Device Description: 100 mL USP Sterile Saline, Screw Top Container
Catalog Number
-
Brand Name
McKesson
Version/Model Number
37-6240
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)
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
96e9d004-e14d-41dd-9d6c-ffd0e3817740
Public Version Date
June 09, 2022
Public Version Number
3
DI Record Publish Date
May 12, 2021
Package DI Number
00612479168565
Quantity per Package
48
Contains DI Package
00612479199545
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 |