Duns Number:200103823
Device Description: Rescuer Adult disposable manual resuscitator with 2900 Ml reservoir, #5 cushion mask and 2 Rescuer Adult disposable manual resuscitator with 2900 Ml reservoir, #5 cushion mask and 2 m crush proof oxygen tubing with universal style connector
Catalog Number
4000U
Brand Name
Rescuer BVM Manual Resuscitator with Universal Tubing
Version/Model Number
4000U
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
08e31556-cad0-470c-8234-48a051559f7e
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
February 13, 2017
Package DI Number
B0024000U3
Quantity per Package
12
Contains DI Package
B0024000U0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case of 12
| 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 |