Duns Number:002348191
Device Description: Mouthpiece 15 mm O.D. / 22 mm O.D.
Catalog Number
1565
Brand Name
HUDSON RCI
Version/Model Number
IPN042595
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
BYP
Product Code Name
MOUTHPIECE, BREATHING
Public Device Record Key
2559da62-4b81-4a26-bd1f-3d70030cc502
Public Version Date
March 23, 2020
Public Version Number
2
DI Record Publish Date
January 29, 2020
Package DI Number
14026704594853
Quantity per Package
50
Contains DI Package
34026704594857
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 |