Duns Number:006959555
Device Description: Meijer Aneroid Self-Taking Home BP Kit
Catalog Number
74-5502
Brand Name
Meijer
Version/Model Number
74-5502
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082542,K082542,K082542
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
832c37ce-adc1-4f17-afce-550b30acd1ae
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
30760236653333
Quantity per Package
3
Contains DI Package
00760236653332
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Intermediate
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |