Duns Number:066689993
Device Description: BODYMED UPPER ARM BLOOD PRESSURE MONITOR WITH UNIVERSAL CUFF, DIGITAL, 22CM-52CM
Catalog Number
ZZABP01
Brand Name
BodyMed
Version/Model Number
ZZABP01
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131558,K131558,K131558
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
205204cb-da13-4b36-9b3f-62ed6cd2456c
Public Version Date
February 27, 2020
Public Version Number
4
DI Record Publish Date
September 05, 2016
Package DI Number
20815802014452
Quantity per Package
18
Contains DI Package
10815802014455
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |