Duns Number:198227881
Device Description: ABPM-7100 Ambulatory Blood Pressure Monitor including Monitor Pouch, Adult Cuff, Adult Plu ABPM-7100 Ambulatory Blood Pressure Monitor including Monitor Pouch, Adult Cuff, Adult Plus Cuff, USB Cable; 4 Alkaline AA Batteries (Software Included)
Catalog Number
ABPM-7100S
Brand Name
Welch Allyn, Inc.
Version/Model Number
901050
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZG
Product Code Name
SPIROMETER, DIAGNOSTIC
Public Device Record Key
22da24d2-9239-4625-b3a0-c951bdc96464
Public Version Date
June 21, 2022
Public Version Number
7
DI Record Publish Date
September 17, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |