Duns Number:002348191
Device Description: ISO-GARD CLEAR AIR MASK, 8013 W/FILTER
Catalog Number
8014
Brand Name
HUDSON RCI
Version/Model Number
IPN039054
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CBN
Product Code Name
APPARATUS, GAS-SCAVENGING
Public Device Record Key
c2ded85a-19b2-4a43-b863-3031e4941f5b
Public Version Date
May 13, 2020
Public Version Number
2
DI Record Publish Date
June 18, 2019
Package DI Number
24026704663211
Quantity per Package
20
Contains DI Package
14026704663214
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |