Duns Number:070556204
Device Description: CPAP/Capno Kit, O2MAX Guard Bitrac ED Mask, FIXED FLOW, MED, 3-SET Valve, CO2 Sampling Lin CPAP/Capno Kit, O2MAX Guard Bitrac ED Mask, FIXED FLOW, MED, 3-SET Valve, CO2 Sampling Line, Neb
Catalog Number
670214-KIT
Brand Name
Curaplex
Version/Model Number
670214-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
77a65526-3087-460e-9c4d-e841a81d9f01
Public Version Date
August 16, 2022
Public Version Number
2
DI Record Publish Date
February 28, 2021
Package DI Number
00810094571481
Quantity per Package
15
Contains DI Package
00812277037104
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 |