Duns Number:078497467
Device Description: XL Cuff (33-43 cm) for use with Blood Pressure Monitor Model # BM35 (Type BM35/1)
Catalog Number
162.934
Brand Name
Beurer
Version/Model Number
BM35 XL Cuff (replacement)
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
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
a61fa885-184e-485d-80f0-cc309a6c78a3
Public Version Date
January 21, 2020
Public Version Number
1
DI Record Publish Date
January 13, 2020
Package DI Number
10850003500611
Quantity per Package
50
Contains DI Package
00850003500614
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
| 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. | 90 |
| U | Unclassified | 2 |