Duns Number:200103823
Device Description: Rescuer adult disposable manual resuscitator with 2900 mL reservoir bag, #5 cushion mask a Rescuer adult disposable manual resuscitator with 2900 mL reservoir bag, #5 cushion mask and 2 m crush proof oxygen tubing (Single Unit)
Catalog Number
4000
Brand Name
Rescuer BVM Manual Resuscitator
Version/Model Number
4000
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
8db87435-dc0c-439f-907e-cd270fab34e3
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
May 07, 2015
Package DI Number
B00240006
Quantity per Package
30
Contains DI Package
B00240000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case of 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 |