Duns Number:007941230
Device Description: Sphygmomanometer Aneroid Hand-held Deluxe Mercury-free Large Adult Navy Nylon Cuff With Ra Sphygmomanometer Aneroid Hand-held Deluxe Mercury-free Large Adult Navy Nylon Cuff With Range Marking MediChoice Not Made With Natural Rubber Latex
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
SPG2003
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"
Yes
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
7457f2b1-472c-41f5-b0e7-4e96aa4d9eef
Public Version Date
October 22, 2018
Public Version Number
1
DI Record Publish Date
September 19, 2018
Package DI Number
20885632146395
Quantity per Package
20
Contains DI Package
10885632146398
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |