Duns Number:961027315
Device Description: Prefilled Specimen Container 10% Neutral Buffered Formalin 60mL with 30mL fill
Catalog Number
CH60NBF
Brand Name
CARDINAL HEALTH
Version/Model Number
CH60NBF
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"
-
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
IFP
Product Code Name
FORMALIN, NEUTRAL BUFFERED
Public Device Record Key
e0114557-b10d-4543-9c4e-3b745cba3e68
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
July 14, 2018
Package DI Number
50885380131781
Quantity per Package
96
Contains DI Package
10885380131783
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 | 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 |