Duns Number:002348191
Device Description: MASK HARNESS,ADULT,REUSABLE
Catalog Number
15910
Brand Name
HUDSON RCI
Version/Model Number
IPN042638
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
-
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
f2013b2b-fcce-4d87-9b13-9a7cda9661c7
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
September 15, 2018
Package DI Number
24026704580525
Quantity per Package
10
Contains DI Package
04026704580521
Package Discontinue Date
September 30, 2019
Package Status
Not 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 |