Duns Number:194550042
Device Description: Imagenetics Specimen Collection Kit, Sanford Sioux Falls
Catalog Number
CA23875
Brand Name
Aero-Med
Version/Model Number
CA23875
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
OIB
Product Code Name
Blood and urine collection kit (excludes HIV testing)
Public Device Record Key
35bd3455-c661-4e40-9d60-6c7b6e4c7c7c
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
June 13, 2019
Package DI Number
50885380170810
Quantity per Package
10
Contains DI Package
10885380170812
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 |