Duns Number:604208868
Device Description: #1831 Infection Control Kit / Personal Protection KitContents: 1 ea. Isolation Gown, 1 ea. #1831 Infection Control Kit / Personal Protection KitContents: 1 ea. Isolation Gown, 1 ea. Earloop Mask / Face Shield, 2 ea. Glove L/F, 1 ea. Sani-Hands Antimicrobial, 1 ea. Biohazard Bag 24x24"
Catalog Number
1831
Brand Name
Motion Medical Distributing
Version/Model Number
1831
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OKH
Product Code Name
Body Fluids Barrier Kit
Public Device Record Key
45a5d35a-0795-4e07-83f8-c8f2d131a8d9
Public Version Date
December 14, 2020
Public Version Number
1
DI Record Publish Date
December 04, 2020
Package DI Number
25060498452094
Quantity per Package
25
Contains DI Package
15060498452097
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 190 |