Duns Number:791014871
Device Description: Standard Sphyg., Nylon Black, Lg. Adult Latex Free
Catalog Number
2024x
Brand Name
Tech-Med
Version/Model Number
2024x
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193259,K193259
Product Code
DXQ
Product Code Name
blood pressure cuff
Public Device Record Key
b70f900e-0e81-4461-a738-334ad752d804
Public Version Date
May 23, 2022
Public Version Number
9
DI Record Publish Date
September 24, 2016
Package DI Number
20665973017031
Quantity per Package
40
Contains DI Package
00665973017037
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |
| U | Unclassified | 1 |