Duns Number:189583599
Device Description: Balance Aneroid Sphygmomanometer (Free Basic Stethoscope or $10 voucher for Stethoscope)
Catalog Number
-
Brand Name
Greater Goods
Version/Model Number
0610
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
K090014,K090014
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
e1632b5f-bce8-4f35-8eb8-ec0a3abf617e
Public Version Date
November 11, 2020
Public Version Number
1
DI Record Publish Date
November 03, 2020
Package DI Number
10875011006108
Quantity per Package
25
Contains DI Package
00875011006101
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 30 |