Duns Number:961027315
Device Description: Specimen Bag, Biohazard, 13in x 18in, adhesive seal, front pouch, orange, St Luke Universi Specimen Bag, Biohazard, 13in x 18in, adhesive seal, front pouch, orange, St Luke University Health Network Only
Catalog Number
AD13X18SLO
Brand Name
CARDINAL HEALTH
Version/Model Number
AD13X18SLO
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
d9d4fd49-1389-4d00-ae2b-85d9e7364333
Public Version Date
January 17, 2019
Public Version Number
2
DI Record Publish Date
December 17, 2018
Package DI Number
50885380155350
Quantity per Package
10
Contains DI Package
20885380155359
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 |