Duns Number:092673953
Device Description: Transport Elbow, Adapter 8' Oxygen Tubing with Threaded Nut, 3L not made with latex bag
Catalog Number
-
Brand Name
Disposable Medical Hyperinflation System
Version/Model Number
0426
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
c95d7bfd-9998-421b-8201-f72040679c77
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
September 25, 2018
Package DI Number
10709078006033
Quantity per Package
20
Contains DI Package
00709078006036
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 |