Duns Number:002348191
Device Description: Manual Resuscitator, Durable, Infant - with Small Infant (Size 0)Resuscitation Mask and Re Manual Resuscitator, Durable, Infant - with Small Infant (Size 0)Resuscitation Mask and Reservoir
Catalog Number
5347
Brand Name
HUDSON RCI
Version/Model Number
IPN039379
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
48698adc-72bc-4cc1-8869-626e77a4bb84
Public Version Date
March 04, 2021
Public Version Number
10
DI Record Publish Date
October 23, 2019
Package DI Number
34026704662402
Quantity per Package
24
Contains DI Package
14026704662408
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 |