Duns Number:069009268
Device Description: Infant Resuscitator with Corrugated Tubing, Manometer, Filter, 40cm H2O Pop-Off & Size 0, Infant Resuscitator with Corrugated Tubing, Manometer, Filter, 40cm H2O Pop-Off & Size 0, 1 & 2 Masks
Catalog Number
-
Brand Name
AirFlow
Version/Model Number
AF3140MC-MOD12
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
d040fffe-d81a-4568-a5ad-bd027b79bc1e
Public Version Date
March 19, 2020
Public Version Number
1
DI Record Publish Date
March 11, 2020
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 165 |