Duns Number:796083392
Device Description: BP Cuff, Adult Large, 1 TubeBP00-2105 = 5 packBP00-2120 = 20 pack
Catalog Number
-
Brand Name
Accu-Read
Version/Model Number
BP00-2101
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
K171889,K171889,K171889
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
de3fe0fe-93fd-4ec8-b22c-858b14c0df99
Public Version Date
September 06, 2019
Public Version Number
1
DI Record Publish Date
August 29, 2019
Package DI Number
20858293006438
Quantity per Package
20
Contains DI Package
00858293006434
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 |