Duns Number:002348191
Device Description: Manual Resuscitator, Durable, Child - with Small Svhild (Size 2) Resuscitation Mask and Re Manual Resuscitator, Durable, Child - with Small Svhild (Size 2) Resuscitation Mask and Reservoir
Catalog Number
5346
Brand Name
Hudson RCI
Version/Model Number
IPN044931
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
badf1119-ef32-4fdd-a49e-f658ab2f116a
Public Version Date
October 26, 2020
Public Version Number
2
DI Record Publish Date
March 15, 2019
Package DI Number
24026704613636
Quantity per Package
24
Contains DI Package
04026704613632
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 |