Duns Number:038305402
Device Description: Bi-Level Circuit for Respironics Vision & Std30
Catalog Number
-
Brand Name
Ventlab
Version/Model Number
PRO-7140
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
K040726,K040726
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
e4c8afa2-86cc-49bd-bf10-b412cb7c0bd9
Public Version Date
October 24, 2022
Public Version Number
5
DI Record Publish Date
September 27, 2016
Package DI Number
20889483104047
Quantity per Package
10
Contains DI Package
10889483104040
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 612 |