Duns Number:002348191
Device Description: REPLACEMENT PARTNONREBREATHINGVALVE HOUSINGWITHOUT PRESSURE RELIEF
Catalog Number
51014
Brand Name
HUDSON RCI
Version/Model Number
IPN039365
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
BTM
Product Code Name
Ventilator, emergency, manual (resuscitator)
Public Device Record Key
2959e3b3-a084-4ba6-8753-8d3daf2bce67
Public Version Date
January 25, 2021
Public Version Number
5
DI Record Publish Date
October 04, 2019
Package DI Number
34026704662266
Quantity per Package
50
Contains DI Package
14026704662262
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 |