Duns Number:544328369
Device Description: 1,Disposable for single patient use only,to avoid potential cross-infection.2,Material:whi 1,Disposable for single patient use only,to avoid potential cross-infection.2,Material:white color PVC coated non-woven fabrics3,One-piece/bladderless design,neat and comfortable4,Round corner design,with better appearance and patient's comfort5,Compatible with most brands of patient monitors6,Full range of 13 sizes to fit most patient's arm from neonate to thigh7,Available with single tube and double tubes8,Latex Free&biocompatibility tested9,Compliance with ANSI/AAMI SP10-2002,EN60601-1:1990
Catalog Number
-
Brand Name
Vistarmed
Version/Model Number
Disposable 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
Yes
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
K152465
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
73456dcd-ddf7-40a7-a550-f975e496a0f1
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 |