Duns Number:002348191
Device Description: BREATHING CIRCUIT,HEATED WIRE NIV
Catalog Number
780-98
Brand Name
HUDSON RCI
Version/Model Number
IPN045233
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K031383,K031383
Product Code
BTT
Product Code Name
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Public Device Record Key
1fab4962-9751-4259-a514-0d3f42f8f561
Public Version Date
October 24, 2022
Public Version Number
7
DI Record Publish Date
September 16, 2016
Package DI Number
24026704598315
Quantity per Package
10
Contains DI Package
04026704598311
Package Discontinue Date
January 11, 2021
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |