Duns Number:604208868
Device Description: #1836 Isolation Kit / Body Fluids Barrier KitContents: Biohazard Bag, Biohazard Linen Bag, #1836 Isolation Kit / Body Fluids Barrier KitContents: Biohazard Bag, Biohazard Linen Bag, Face Shield, Safety Glasses, BZK Prep Pad, Sani-Hands Prep Pad, Earloop Mask, Bouffant Cap, Solidifier Pouch, Scoop/Scraper, Emesis Bag, Nitrile Gloves (x2)
Catalog Number
1836
Brand Name
Motion Medical Distributing
Version/Model Number
1836
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
9435ba83-0c69-48ac-a385-00052de973e9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 07, 2016
Package DI Number
25060498451134
Quantity per Package
25
Contains DI Package
15060498451137
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 |