Duns Number:002348191
Device Description: LIFESAVER® Pediatric Manual Resuscitator with Mask and Flow Diverter
Catalog Number
5367
Brand Name
HUDSON RCI
Version/Model Number
IPN039348
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
K964719,K964719,K964719
Product Code
BTM
Product Code Name
Ventilator, emergency, manual (resuscitator)
Public Device Record Key
16b078ba-5dd3-47a6-8f11-a5265c66bcc5
Public Version Date
May 11, 2021
Public Version Number
9
DI Record Publish Date
September 17, 2019
Package DI Number
34026704662655
Quantity per Package
6
Contains DI Package
14026704662651
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |