Duns Number:002348191
Device Description: MASK HARNESS,PEDIATRIC,REUSABLE
Catalog Number
15911
Brand Name
HUDSON RCI
Version/Model Number
IPN049874
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"
-
For Single-Use
-
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
BTK
Product Code Name
STRAP, HEAD, GAS MASK
Public Device Record Key
36a3ceaf-e8ee-448d-9960-4ecbf82c517d
Public Version Date
January 18, 2021
Public Version Number
3
DI Record Publish Date
April 23, 2019
Package DI Number
34026704640479
Quantity per Package
10
Contains DI Package
14026704640475
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 |