Duns Number:206449154
Device Description: The infant EASY GRIP® Silicone Bag Valve Mask Resuscitator is a reusable device for manual The infant EASY GRIP® Silicone 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 INFANT patient. When used with a supplemental oxygen supply, the device may provide 100% oxygen on every squeeze of the bag.The Infant EASY GRIP resuscitator comes standard with a Pressure Relief Valve set at 40 cm H2O which can be overridden by the operator.
Catalog Number
01BM3620
Brand Name
EASY GRIP
Version/Model Number
01BM3620
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"
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For Single-Use
-
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
b9151dc9-cd26-446d-b063-4cd1dbf34196
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 26, 2015
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 |
|---|---|---|
| 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 |