Duns Number:080361159
Device Description: SPHYGMOMANOMETER, ANEROID, ADULT LARGE, 1/EA
Catalog Number
-
Brand Name
TIGER MEDICAL SPHYGMOMANOMETER
Version/Model Number
SMT503
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)
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
fd60f92d-b31b-4d29-a571-afbd4ffc32bb
Public Version Date
August 10, 2022
Public Version Number
1
DI Record Publish Date
August 02, 2022
Package DI Number
10840216101545
Quantity per Package
50
Contains DI Package
00840216101548
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |