Duns Number:785952607
Device Description: HEATED WIRE SYSTEM WITH AUTO FILL CHAMBER
Catalog Number
-
Brand Name
N/A
Version/Model Number
2026031
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
K092129,K092129
Product Code
BZE
Product Code Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Public Device Record Key
0072b262-2488-46ac-9c0a-6b171c56cf36
Public Version Date
October 24, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
05030267106981
Quantity per Package
7
Contains DI Package
05030267095872
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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |