Duns Number:021249224
Device Description: The Model 100026-PA-SA AC Power Adapter Subassembly is a Model 100026-PA AC Power Adapter The Model 100026-PA-SA AC Power Adapter Subassembly is a Model 100026-PA AC Power Adapter as a subassembly. This includes Model 100026-PA, but is packaged seperately from a system configuration.
Catalog Number
-
Brand Name
AC Power Adapter Subassembly Kit
Version/Model Number
1000026-PA-SA
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132454
Product Code
DWJ
Product Code Name
System, Thermal Regulating
Public Device Record Key
be53c96a-33aa-4c82-9a4c-f8f137b039ae
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |