Duns Number:401235817
Device Description: The Meditech ABPM-04 Ambulatory Blood Pressure Monitor automatically measures the systolic The Meditech ABPM-04 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as programmed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.
Catalog Number
-
Brand Name
Meditech
Version/Model Number
ABPM-04 (BP4)
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051149
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
b30b8c3c-cdc0-4ea8-a1e3-76ae294f7a83
Public Version Date
December 03, 2021
Public Version Number
1
DI Record Publish Date
November 25, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |