Duns Number:002348191
Device Description: Adult Nonrebreathing Mask with Safety Vent and 2.1 m Tubing
Catalog Number
1059
Brand Name
HUDSON RCI
Version/Model Number
IPN913893
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
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
KGB
Product Code Name
MASK, OXYGEN, NON-REBREATHING
Public Device Record Key
eaa7f302-bc71-4361-9b0c-710145e43e91
Public Version Date
August 19, 2020
Public Version Number
2
DI Record Publish Date
May 05, 2020
Package DI Number
24026704648102
Quantity per Package
50
Contains DI Package
14026704648105
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 |