Duns Number:985578451
Device Description: A collection of noninvasive devices intended to be used for the collection, and preservati A collection of noninvasive devices intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation.
Catalog Number
UO305, UO01S
Brand Name
LetsGetChecked Urine Sample Collection Kit (SM02)
Version/Model Number
UO305, UO01S
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
OIE
Product Code Name
Urine Collection Kit (Excludes Hiv Testing)
Public Device Record Key
eae6cb6c-c7f5-44b3-806e-b99438abdd47
Public Version Date
April 07, 2022
Public Version Number
1
DI Record Publish Date
March 30, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |