Duns Number:206449154
Device Description: The disposable Adult EASY GRIP® Bag Valve Mask Resuscitator is a reusable device for manua The disposable Adult EASY GRIP® Bag Valve Mask Resuscitator is a reusable device for manual ventilation. It is designed for use in various clinical settings to provide respiratory support to the respiratory distressed or non-breathing ADULT patient. When used with a supplemental oxygen supply, the device may provide 100% oxygen on every squeeze of the bag.
Catalog Number
01BM3501-CS
Brand Name
EASY GRIP
Version/Model Number
01BM3501
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)
Yes
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
a7ee42ec-0553-4eec-ae62-6cb461c3c677
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 26, 2015
Package DI Number
17540195000251
Quantity per Package
12
Contains DI Package
07540195000254
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugated carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |