Duns Number:514918791
Device Description: "Pocket BVM is a manual emergency ventilator whose purpose is to manually apply positive p "Pocket BVM is a manual emergency ventilator whose purpose is to manually apply positive pressure to a patient’s airways to support ventilation and oxygenation. The modified Pocket BVM incorporates bags and valve assemblies and is intended to provide emergency respiratory support to a patient through a tube inserted into the patient's airway or a face mask. The Pocket BVM device continues to maintain the functionality of existing devices and also has the advantage of small external dimensions (when packed) and light weight. It can be unpacked and made operational in seconds."
Catalog Number
-
Brand Name
Pocket BVM TM EXT
Version/Model Number
MBVM EXT
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
6dfef2fd-5485-4678-8236-76045467b207
Public Version Date
February 08, 2019
Public Version Number
3
DI Record Publish Date
March 29, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |