Duns Number:002034635
Device Description: Child Calibrated V-Lok Cuff & Single Stem Non LatexInflation Bag with Male Rectus Connecto Child Calibrated V-Lok Cuff & Single Stem Non LatexInflation Bag with Male Rectus Connector
Catalog Number
1881SSOCNL
Brand Name
BAUM
Version/Model Number
1881SSOCNL
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
a27f7ffe-3442-4786-978d-0f9ac4b56a74
Public Version Date
October 09, 2019
Public Version Number
1
DI Record Publish Date
October 01, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 465 |