Duns Number:080456871
Device Description: Expiratory Filter for Patient Circuit
Catalog Number
12152
Brand Name
3100 HFOV
Version/Model Number
12152
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
P890057,P890057
Product Code
LSZ
Product Code Name
VENTILATOR, HIGH FREQUENCY
Public Device Record Key
840fb8d8-2def-45f0-8d52-170b45a079e3
Public Version Date
March 15, 2021
Public Version Number
1
DI Record Publish Date
March 05, 2021
Package DI Number
50190752148879
Quantity per Package
25
Contains DI Package
10190752148871
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 780 |
| 3 | A medical device with high risk that requires premarket approval | 65 |
| U | Unclassified | 1 |