Duns Number:002348191
Device Description: Mouthpiece 15 mm O.D. / 22 mm O.D.
Catalog Number
1565
Brand Name
HUDSON RCI
Version/Model Number
IPN913926
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
34ea0bc6-a07d-4476-bdf4-ac5462a5a4e6
Public Version Date
August 19, 2020
Public Version Number
3
DI Record Publish Date
May 03, 2019
Package DI Number
24026704656718
Quantity per Package
50
Contains DI Package
14026704656711
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 |