Duns Number:071595540
Device Description: DSP LW:UNSHLD;72"3LD,SNP,BWGR
Catalog Number
RDA72-03
Brand Name
NA
Version/Model Number
RDA72-03
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
K912415,K912415,K912415,K912415
Product Code
BZQ
Product Code Name
Monitor, breathing frequency
Public Device Record Key
d5fd9754-dd11-4f6f-88fc-44d84476fc1b
Public Version Date
October 14, 2020
Public Version Number
2
DI Record Publish Date
August 27, 2020
Package DI Number
30653405002127
Quantity per Package
25
Contains DI Package
20653405002120
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 | 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 |