Duns Number:080456871
Device Description: 1/4 Liter Neoprene Flow-Inflating Bag with Pre-Attached 7’ (2.1 m) Oxygen Tubing and 7’ (2 1/4 Liter Neoprene Flow-Inflating Bag with Pre-Attached 7’ (2.1 m) Oxygen Tubing and 7’ (2.1 m) Manometer Tubing, Neonatal Valved Mask
Catalog Number
2K80231
Brand Name
AirLife™
Version/Model Number
2K80231
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
BZR
Product Code Name
Mixer, breathing gases, anesthesia inhalation
Public Device Record Key
f8290017-f849-450f-80e8-f610b459fedc
Public Version Date
May 11, 2021
Public Version Number
1
DI Record Publish Date
May 03, 2021
Package DI Number
50190752156409
Quantity per Package
20
Contains DI Package
10190752156401
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 780 |
| 3 | A medical device with high risk that requires premarket approval | 65 |
| U | Unclassified | 1 |