Duns Number:002348191
Device Description: ISO-GARD CLEAR AIR MASK, 8011 W/FILTER
Catalog Number
8012
Brand Name
HUDSON RCI
Version/Model Number
IPN039052
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
CBN
Product Code Name
APPARATUS, GAS-SCAVENGING
Public Device Record Key
f682f2f1-c76a-421f-bee7-b517b801e720
Public Version Date
May 13, 2020
Public Version Number
2
DI Record Publish Date
June 18, 2019
Package DI Number
24026704663198
Quantity per Package
20
Contains DI Package
14026704663191
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |