Duns Number:010712461
Device Description: FILTER,C/B M/P,27.0ID,30.1OD
Catalog Number
-
Brand Name
Curaplex
Version/Model Number
301-PFR9WC
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
K042758,K042758
Product Code
BZG
Product Code Name
SPIROMETER, DIAGNOSTIC
Public Device Record Key
8c24c482-2bea-4537-b7cc-1128c3a80a82
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 16, 2016
Package DI Number
00812574024067
Quantity per Package
100
Contains DI Package
00812574024784
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 | 92 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |