Duns Number:108999095
Device Description: Pocket Aneroid Sphyg,Child, Black, HOP PL, LF
Catalog Number
760CHOPLF
Brand Name
Hopkins
Version/Model Number
760CHOPLF
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 11, 2019
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
-
Product Code
DXQ
Product Code Name
Blood Pressure Cuff
Public Device Record Key
43ceb7b4-0766-440b-9214-32cc62f70325
Public Version Date
April 12, 2019
Public Version Number
3
DI Record Publish Date
July 21, 2017
Package DI Number
00634782534561
Quantity per Package
20
Contains DI Package
00634782034719
Package Discontinue Date
April 11, 2019
Package Status
Not in Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2395 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1769 |