Duns Number:600850213
Device Description: circuitGuard® ThermoFlo® 1 Filter – Combined Heat Moisture Exchanger, Bacterial Viral Filt circuitGuard® ThermoFlo® 1 Filter – Combined Heat Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow
Catalog Number
-
Brand Name
circuitGuard® ThermoFlo®
Version/Model Number
6126
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
-
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
K090738,K090738
Product Code
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
92a7ca13-50b1-4846-a0e3-1a9fb40624db
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
July 21, 2021
Package DI Number
10810050852217
Quantity per Package
100
Contains DI Package
00810050852210
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 | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |