Duns Number:058716649
Device Description: "Pediatric Blood Pressure Disposable Cuffs 3-6in (8-15 cm)(BP CUFF, DISP, 8-15CM, VERIS, "Pediatric Blood Pressure Disposable Cuffs 3-6in (8-15 cm)(BP CUFF, DISP, 8-15CM, VERIS,MC)(85276697)"
Catalog Number
3010534
Brand Name
MEDRAD® Veris™ 8600 Vital Signs Monitor
Version/Model Number
3010534
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
K042569,K042569
Product Code
MWI
Product Code Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Public Device Record Key
6ba57ca8-519f-496e-adb9-559151f7b9e6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 23, 2017
Package DI Number
10616258009435
Quantity per Package
10
Contains DI Package
00616258009438
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 360 |