Duns Number:604208868
Device Description: #1874 - Isolation Kit BasicContents: 1 ea. Mask Earloop, 2 ea. Glove LG L/F, 2 ea. Alcohol #1874 - Isolation Kit BasicContents: 1 ea. Mask Earloop, 2 ea. Glove LG L/F, 2 ea. Alcohol Prep Pad, 2 ea. Sani-Hands Antimicrobial, 1 ea. Biohazard Bag
Catalog Number
1874
Brand Name
Motion Medical Distributing
Version/Model Number
1874
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
f430aa6f-7cc1-48c9-9168-6617fe5cdc0d
Public Version Date
February 23, 2021
Public Version Number
1
DI Record Publish Date
February 15, 2021
Package DI Number
25060498452155
Quantity per Package
25
Contains DI Package
15060498452158
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 |