Duns Number:961027315
Device Description: Mucus Specimen Trap
Catalog Number
C30200A
Brand Name
CARDINAL HEALTH
Version/Model Number
C30200A
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYZ
Product Code Name
TRAP, STERILE SPECIMEN
Public Device Record Key
e422cb5b-e19c-48c4-ab02-c0b1ccbdf0f1
Public Version Date
July 22, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2016
Package DI Number
50885380119796
Quantity per Package
24
Contains DI Package
10885380119798
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 |