Duns Number:038305402
Device Description: Small Nasal CPAP Kit w/ Soft Headgear 10/cs
Catalog Number
-
Brand Name
Ventlab
Version/Model Number
CS4000S
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
84795993-b059-43b1-875b-ca3dc5136d71
Public Version Date
October 24, 2022
Public Version Number
5
DI Record Publish Date
October 01, 2016
Package DI Number
20889483097608
Quantity per Package
10
Contains DI Package
10889483097601
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 |