Duns Number:194550042
Device Description: Pathology Specimen Transport Kit, Medical Center of Wisconsin Only
Catalog Number
CA29050
Brand Name
Aero-Med
Version/Model Number
CA29050
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
79fa3bf2-b0b9-499f-886b-955cf0cc05cf
Public Version Date
March 22, 2021
Public Version Number
1
DI Record Publish Date
March 13, 2021
Package DI Number
50885380177611
Quantity per Package
20
Contains DI Package
10885380177613
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 | 467 |
2 | A medical device with a moderate to high risk that requires special controls. | 14 |