Duns Number:105932508
Device Description: Classic Aneroid Sphygmomanometer, Black Nylon Cuff, Adult, Latex, School Health Logo (AJ56 Classic Aneroid Sphygmomanometer, Black Nylon Cuff, Adult, Latex, School Health Logo (AJ56107)
Catalog Number
-
Brand Name
School Health
Version/Model Number
20-207-014-SH-L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
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
-
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
a5215794-e4ee-4930-bc7d-9f4571f93f5d
Public Version Date
December 24, 2018
Public Version Number
4
DI Record Publish Date
December 24, 2016
Package DI Number
00845821028297
Quantity per Package
24
Contains DI Package
00845821028280
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 | 658 |
2 | A medical device with a moderate to high risk that requires special controls. | 163 |