Duns Number:036985604
Device Description: The A-Series High Density Mobile Light is used with the HarmonyAIR A-Series Lighting Syste
Catalog Number
LAH0055
Brand Name
HarmonyAIR
Version/Model Number
A-Series Mobile Light
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSS
Product Code Name
Light, surgical, floor standing
Public Device Record Key
f888c6d2-d5fc-4a0a-ba96-0d949f748203
Public Version Date
August 09, 2021
Public Version Number
4
DI Record Publish Date
May 29, 2020
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 | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |