Duns Number:092673953
Device Description: Hyperinflation, System, 1/2L Bag (Letx Free), 7' O2 and Manometer, Infant Mask, 40 CM pop Hyperinflation, System, 1/2L Bag (Letx Free), 7' O2 and Manometer, Infant Mask, 40 CM pop off Valve
Catalog Number
-
Brand Name
Disposable Hyperinflation System
Version/Model Number
7-N7905-I-MAN-P
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
c4789950-7439-4456-a60d-6e0c277d908f
Public Version Date
December 08, 2020
Public Version Number
1
DI Record Publish Date
November 30, 2020
Package DI Number
10709078011488
Quantity per Package
12
Contains DI Package
00709078011481
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 |