Duns Number:070556204
Device Description: CPAP/Capnography Kit, O2MAX Neb Bitrac ED Mask, Adult LG, 5-SET Valve, CO2 Sampling Line
Catalog Number
670130-KIT
Brand Name
Curaplex
Version/Model Number
670130-KIT
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
-
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
7a52c7f9-bd84-4b75-9e2f-ba4fa0167e45
Public Version Date
August 16, 2022
Public Version Number
4
DI Record Publish Date
December 14, 2016
Package DI Number
00810094570811
Quantity per Package
15
Contains DI Package
00815277021753
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |