Duns Number:002348191
Device Description: HUMIDIFICATION CHAMBER SINGLE PATIENT USE
Catalog Number
500-20
Brand Name
HUDSON RCI
Version/Model Number
IPN039535
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
K001213,K001213,K001213
Product Code
BTT
Product Code Name
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Public Device Record Key
cbdd8d98-f27a-47dd-9056-fbe8c952bcd6
Public Version Date
August 28, 2020
Public Version Number
1
DI Record Publish Date
August 20, 2020
Package DI Number
34026704662778
Quantity per Package
18
Contains DI Package
14026704662774
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 | 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 |