Duns Number:118793157
Catalog Number
-
Brand Name
Hanks' Balanced Salt Solution (HBSS)
Version/Model Number
14175079
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 25, 2022
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
-
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
-
Product Code
KIP
Product Code Name
FORMULATIONS, BALANCED SALT SOLUTIONS
Public Device Record Key
b8072ed6-1606-4436-97df-c4c270fd103e
Public Version Date
May 26, 2022
Public Version Number
4
DI Record Publish Date
August 04, 2016
Package DI Number
30190302002879
Quantity per Package
6
Contains DI Package
10190302002875
Package Discontinue Date
May 25, 2022
Package Status
Not 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 | 634 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| 3 | A medical device with high risk that requires premarket approval | 12 |