Duns Number:038305402
Device Description: Stat-Check Adult Resuscitator with Inflatable Bag Reservoir, PEEP Valve + Adapter, Mask & Stat-Check Adult Resuscitator with Inflatable Bag Reservoir, PEEP Valve + Adapter, Mask & MaxCap
Catalog Number
-
Brand Name
Stat-Check
Version/Model Number
SC9200MBP-X
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
K982215,K982215
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
a604211b-4ed7-49b0-b8cc-71a83c6f1f79
Public Version Date
December 25, 2019
Public Version Number
1
DI Record Publish Date
December 17, 2019
Package DI Number
30889483230644
Quantity per Package
10
Contains DI Package
10889483230640
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |