Duns Number:036985604
Device Description: The Harmony rShield 31.5-inch Tube with Spring Arm is used with the HarmonyAIR M-Series Su The Harmony rShield 31.5-inch Tube with Spring Arm is used with the HarmonyAIR M-Series Suspension System.
Catalog Number
LM0093
Brand Name
HarmonyAIR
Version/Model Number
M-Series Suspension
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
FQO
Product Code Name
TABLE, OPERATING-ROOM, AC-POWERED
Public Device Record Key
cd47963e-31ce-4aba-b7ad-846f3f5f57c2
Public Version Date
January 27, 2021
Public Version Number
2
DI Record Publish Date
May 15, 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 |