Duns Number:038305402
Device Description: Pediatric Resuscitator with Collapsible Accumulator, Integrated Manometer, 40cm H2O Pop-Of Pediatric Resuscitator with Collapsible Accumulator, Integrated Manometer, 40cm H2O Pop-Off, B/V Filter, PEEP Valve & Mask
Catalog Number
-
Brand Name
V-Care
Version/Model Number
VN2102MXP-F
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"
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
-
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
0df03681-369e-4278-aeda-43c3f970d407
Public Version Date
December 12, 2019
Public Version Number
1
DI Record Publish Date
December 04, 2019
Package DI Number
30889483230651
Quantity per Package
10
Contains DI Package
10889483230657
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 612 |