Duns Number:544328369
Device Description: 1,Reusable for multi patient use2,Compatible with most brands of patient monitors3,Full ra 1,Reusable for multi patient use2,Compatible with most brands of patient monitors3,Full range to fit most patient's arm from neonate to thigh4,Easy to clean5,Latex Free&biocompatibility tested6,Compliance with ANSI/AAMI SP10-2002,EN60601-1:1990
Catalog Number
-
Brand Name
Vistarmed
Version/Model Number
Reusable blood pressure cuff
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152468
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
b7fe8056-3bea-4646-8b5e-2cb635a8035c
Public Version Date
July 30, 2020
Public Version Number
1
DI Record Publish Date
July 22, 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. | 243 |