Duns Number:002348191
Device Description: HUDSON RCI CLEAR COMFORT AIR CUSHION FACE MASK MEDIUM ADULT
Catalog Number
15808
Brand Name
HUDSON RCI
Version/Model Number
IPN049610
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
BSJ
Product Code Name
MASK, GAS, ANESTHETIC
Public Device Record Key
5ba7329f-c6d1-4279-8488-1c43117715ba
Public Version Date
March 04, 2020
Public Version Number
2
DI Record Publish Date
May 08, 2019
Package DI Number
34026704630012
Quantity per Package
30
Contains DI Package
14026704630018
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 |