Duns Number:022721133
Device Description: Patient Kit, with 1600HF cannula and Bubble Humidifier (6-15 LPM) with 6 PSI
Catalog Number
SO-2052
Brand Name
N/A
Version/Model Number
SO-2052
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
-
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
K113542,K113542
Product Code
BTT
Product Code Name
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Public Device Record Key
794b96ca-6765-463b-b303-d671519d9dfa
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 28, 2017
Package DI Number
10607411940689
Quantity per Package
10
Contains DI Package
00607411940682
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 | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |