Duns Number:047069263
Catalog Number
503029
Brand Name
Transcend
Version/Model Number
Mobile Power Adapter
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132127
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
a478625e-a8fe-402f-b246-b34d8be84893
Public Version Date
February 06, 2020
Public Version Number
2
DI Record Publish Date
January 03, 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 | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 32 |