Duns Number:796083392
Device Description: BP Cuff, Large Adult, 32-42 cm, 1 Tube
Catalog Number
-
Brand Name
SoftCheck
Version/Model Number
ST3242FLC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K940214,K940214
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
6cc41ba7-8a84-466c-9201-5dc868940131
Public Version Date
September 09, 2019
Public Version Number
1
DI Record Publish Date
August 30, 2019
Package DI Number
10858293006622
Quantity per Package
20
Contains DI Package
00858293006625
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |