Duns Number:961027315
Device Description: Specimen Bag, Blue, 12x15, Cleveland Clinic Foundation Only
Catalog Number
CH12X15BLU
Brand Name
CARDINAL HEALTH
Version/Model Number
CH12X15BLU
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
500250ad-7dcd-48e8-b065-028bc094563d
Public Version Date
April 17, 2019
Public Version Number
1
DI Record Publish Date
April 09, 2019
Package DI Number
50885380154179
Quantity per Package
10
Contains DI Package
20885380154178
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 |