Duns Number:106712748
Catalog Number
-
Brand Name
Pneupac
Version/Model Number
122004
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"
-
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
K970158,K970158
Product Code
CBK
Product Code Name
VENTILATOR, CONTINUOUS, FACILITY USE
Public Device Record Key
a5276a96-49d9-4063-9322-bc6f575c8c9a
Public Version Date
October 24, 2022
Public Version Number
6
DI Record Publish Date
September 01, 2015
Package DI Number
30610586038284
Quantity per Package
15
Contains DI Package
10610586038280
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 686 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 1 |