Duns Number:070556204
Device Description: ClearPath Bypass HME
Catalog Number
301-1014
Brand Name
Curaplex
Version/Model Number
301-1014
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
-
Product Code
BYD
Product Code Name
CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
Public Device Record Key
7d2804bc-7c8e-427c-86dd-3bf174c6021e
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
December 15, 2018
Package DI Number
00812277032000
Quantity per Package
25
Contains DI Package
00812277031997
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |