Duns Number:830432451
Device Description: Adult Manual Resuscitator, Oxygen Resevoir Bag, Medium Adult Mask, Pressure limiting valve Adult Manual Resuscitator, Oxygen Resevoir Bag, Medium Adult Mask, Pressure limiting valve with lock, 7' O2 Tubing
Catalog Number
2K001
Brand Name
AirLife
Version/Model Number
2K7001
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
2cf28bf2-12ba-4fd4-a1a9-8adfc600c95b
Public Version Date
October 26, 2020
Public Version Number
4
DI Record Publish Date
October 24, 2015
Package DI Number
50885403220461
Quantity per Package
6
Contains DI Package
10885403220463
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 876 |
| 3 | A medical device with high risk that requires premarket approval | 29 |