Duns Number:106908437
Device Description: MDI BEDSIDE URINARY DRAINAGE SET, 1-EACH
Catalog Number
-
Brand Name
MICROTEK
Version/Model Number
1
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCN
Product Code Name
Urinary drainage collection kit, for indwelling catheter
Public Device Record Key
2b284537-ee51-43d6-a587-20d1ba574f0b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 22, 2016
Package DI Number
50748426075213
Quantity per Package
20
Contains DI Package
00748426075218
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 919 |