Duns Number:092673953
Device Description: Anapod Humi-Therm Heated and Humidified Wick Breathing Circuit, 48" Heated Humidified Tran Anapod Humi-Therm Heated and Humidified Wick Breathing Circuit, 48" Heated Humidified Transport Circuit, 48" Expiratory Limb
Catalog Number
-
Brand Name
Anapod Breathing Circuit
Version/Model Number
A9243
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
BZE
Product Code Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Public Device Record Key
9d24dedc-d185-4a2a-96c6-9a13fae7b356
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
July 31, 2020
Package DI Number
10709078008884
Quantity per Package
10
Contains DI Package
00709078008887
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 |