Duns Number:092673953
Device Description: Anapod Humi-Therm Heated and Hunidified Anesthesia Heated Pediatric 96" Circuit
Catalog Number
-
Brand Name
Anapod
Version/Model Number
A9246
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
K904538,K904538
Product Code
BTT
Product Code Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Public Device Record Key
f7e35a68-dc0e-4b5b-9afb-99597571eb8b
Public Version Date
December 24, 2019
Public Version Number
2
DI Record Publish Date
October 18, 2019
Package DI Number
10709078007849
Quantity per Package
10
Contains DI Package
00709078007842
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |