Duns Number:604208868
Device Description: #1826L Isolation Kit LargeContents: (1) Coverall, (2) Glove Extended Cuff, (1) Face Shield #1826L Isolation Kit LargeContents: (1) Coverall, (2) Glove Extended Cuff, (1) Face Shield, (1) Earloop Mask, (1) Safety Glasses, (2) BZK Wipe
Catalog Number
1826L
Brand Name
Motion Medical Distributing
Version/Model Number
1826L
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
89a47eca-f00c-42e8-aaa8-f871ccc63fab
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 13, 2017
Package DI Number
25060498451547
Quantity per Package
10
Contains DI Package
15060498451540
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 |