Duns Number:787828537
Device Description: Deluxe chrome palm aneroid gauge, 300mm HG gauge with stethoscope. Deluxe Calibrated nylon Deluxe chrome palm aneroid gauge, 300mm HG gauge with stethoscope. Deluxe Calibrated nylon cuff with velcro an ddurable latex bladder. Complete unit is packed in a carrying case.
Catalog Number
-
Brand Name
ViaMed
Version/Model Number
13450-BLUE
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K043286,K043286
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
10a43595-340a-47a0-90c3-66feabbd8695
Public Version Date
December 07, 2020
Public Version Number
1
DI Record Publish Date
November 27, 2020
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |