Duns Number:200103823
Device Description: Rescuer disposable infant manual resuscitator with 800 mL reservoir, #1 cushion mask and 2 Rescuer disposable infant manual resuscitator with 800 mL reservoir, #1 cushion mask and 2 m crush proof oxygen tubing.
Catalog Number
4025
Brand Name
Rescuer BVM Manual Resuscitator
Version/Model Number
4025
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K993194,K993194,K993194
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
930807a1-20f5-45fb-985e-6570525379fd
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
May 04, 2015
Package DI Number
B00240256
Quantity per Package
30
Contains DI Package
B00240250
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cas eof 30
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |