Duns Number:071595540
Device Description: Unshielded, 72 Inch, 3 lead, snap connector
Catalog Number
RDA72-03
Brand Name
CONMED
Version/Model Number
RDA72-03
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 26, 2020
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
K912415,K912415,K912415
Product Code
BZQ
Product Code Name
Monitor, breathing frequency
Public Device Record Key
d485e63e-1bc0-4572-be22-d4d5259979f0
Public Version Date
September 25, 2020
Public Version Number
2
DI Record Publish Date
April 29, 2020
Package DI Number
10653405000907
Quantity per Package
25
Contains DI Package
00653405000900
Package Discontinue Date
August 26, 2020
Package Status
Not 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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |