Duns Number:070556204
Device Description: CPAP/Capno Kit, O2MAX Guard, Bitrac ED Mask, FIXED FLOW, LG, 5-SET Valve, Ohmeda, CO2 Samp CPAP/Capno Kit, O2MAX Guard, Bitrac ED Mask, FIXED FLOW, LG, 5-SET Valve, Ohmeda, CO2 Sampling Line
Catalog Number
670226-KIT
Brand Name
Curaplex
Version/Model Number
670226-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"
-
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
-
Product Code
BYE
Product Code Name
Attachment, breathing, positive end expiratory pressure
Public Device Record Key
3d8f433d-7ad4-4b87-ae0a-01c39af9fd92
Public Version Date
April 09, 2021
Public Version Number
1
DI Record Publish Date
April 01, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |