Duns Number:961027315
Device Description: Specimen Transport Bag, CH6X9BHCH
Catalog Number
CH6X9BHCH
Brand Name
CARDINAL HEALTH
Version/Model Number
CH6X9BHCH
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
NNK
Product Code Name
CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE
Public Device Record Key
dab5d35e-7480-4f82-806e-fd1d35d97d5d
Public Version Date
November 26, 2018
Public Version Number
1
DI Record Publish Date
October 24, 2018
Package DI Number
50885380166943
Quantity per Package
10
Contains DI Package
20885380166942
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 |