Duns Number:194550042
Device Description: Kit Urine Foley Collection for Health First Only
Catalog Number
CA43525
Brand Name
Aero-Med
Version/Model Number
CA43525
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"
Yes
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
788c697f-7231-4ae5-bc3b-d4500ddc12d7
Public Version Date
August 26, 2022
Public Version Number
1
DI Record Publish Date
August 18, 2022
Package DI Number
50885380193505
Quantity per Package
50
Contains DI Package
10885380193507
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 |