Duns Number:200103823
Device Description: Adult sized disposable Rescuer BVM Manual Resuscitator with 2900 mL reservoir bag, #5 cush Adult sized disposable Rescuer BVM Manual Resuscitator with 2900 mL reservoir bag, #5 cushion mask, 2 m crush proof oxygen tubing (universal connector) and attached 0-20 cmH2O PEEP valve.
Catalog Number
4000-U-P
Brand Name
Rescuer BVM Manual Resuscitator
Version/Model Number
4000-U-P
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
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
534e2110-3ab0-41d3-92fb-f554196e3f0e
Public Version Date
November 04, 2019
Public Version Number
1
DI Record Publish Date
October 25, 2019
Package DI Number
B0024000UP3
Quantity per Package
12
Contains DI Package
B0024000UP0
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |