Duns Number:961027315
Device Description: Certified Blood Bank Saline; Stabilized Isotonic Saline; Contains No Preservatives; For In Certified Blood Bank Saline; Stabilized Isotonic Saline; Contains No Preservatives; For In Vitro Diagnostic Use Only; Not for Infusion, Injection, or Irrigation; 20 liters
Catalog Number
B3158-1
Brand Name
SP
Version/Model Number
B3158-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 03, 2020
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GIF
Product Code Name
DILUENT, BLOOD CELL
Public Device Record Key
e160cc87-fe45-4c65-a4f0-7453ec2f8ba2
Public Version Date
January 03, 2020
Public Version Number
3
DI Record Publish Date
December 27, 2018
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |