Duns Number:092673953
Device Description: Hyperinflation System, 1/2L Bag (not made with latex), 7' O2 and Pressure Lines, 40 cm H2O Hyperinflation System, 1/2L Bag (not made with latex), 7' O2 and Pressure Lines, 40 cm H2O pop-valve
Catalog Number
-
Brand Name
Hyperinflation
Version/Model Number
900 000 627
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
d63b153c-c6d1-489f-8f08-1b1ebec7250c
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
January 31, 2020
Package DI Number
05707480137510
Quantity per Package
12
Contains DI Package
05707480137503
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 |