Duns Number:092673953
Device Description: Anapod Humi-Therm Heated and Humidified Breathing Circuit, Wick, Adult, 36"/72" BV Filter, Anapod Humi-Therm Heated and Humidified Breathing Circuit, Wick, Adult, 36"/72" BV Filter, Water Trap, 3L Not Made With Latex Breathing Bag
Catalog Number
-
Brand Name
Anapod Humi-Therm
Version/Model Number
9240HTS
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
-
Product Code
BTT
Product Code Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Public Device Record Key
264c1784-996a-4441-adf7-9988d73ea0a3
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
October 02, 2020
Package DI Number
10709078008907
Quantity per Package
10
Contains DI Package
00709078008900
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |