Duns Number:092673953
Device Description: Disposable Hyperinflation System, 2L bag, 7' O2 and pressure lines, adult mask
Catalog Number
-
Brand Name
Hyperinflation AMBU
Version/Model Number
900 000 625
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
K932709,K932709
Product Code
BZR
Product Code Name
Mixer, Breathing Gases, Anesthesia Inhalation
Public Device Record Key
ddc8863d-d211-47f0-8e82-ab3b8bae0fcb
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
July 24, 2019
Package DI Number
05707480137756
Quantity per Package
12
Contains DI Package
05707480137749
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |