Duns Number:604208868
Device Description: #1807 Personal Protection KitContents: (1) Coveralls Advantage XL, (1) Bouffant Cap, (2) S #1807 Personal Protection KitContents: (1) Coveralls Advantage XL, (1) Bouffant Cap, (2) Shoe Cover XL
Catalog Number
1807
Brand Name
Motion Medical Distributing
Version/Model Number
1807
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
63d13425-2dd8-436a-afc2-92d363e20835
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 28, 2017
Package DI Number
25060498451349
Quantity per Package
10
Contains DI Package
15060498451342
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 |