Duns Number:961027315
Device Description: TUBE 50ML POLYPROPYLENE BLU DISP ST
Catalog Number
SP3921-50A
Brand Name
CARDINAL HEALTH
Version/Model Number
SP3921-50A
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
FMH
Product Code Name
CONTAINER, SPECIMEN, STERILE
Public Device Record Key
6b80f221-c7f0-4d74-b3a4-051f499a30fe
Public Version Date
December 27, 2021
Public Version Number
2
DI Record Publish Date
May 15, 2019
Package DI Number
50885380028876
Quantity per Package
20
Contains DI Package
00885380028871
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 |