Duns Number:867673159
Device Description: Pressure PreventionGroup 2 Surfaces Product Description: True LAL LS9000 P/L for Integra 4 Pressure PreventionGroup 2 Surfaces Product Description: True LAL LS9000 P/L for Integra 48"
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
IH-LS900048
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 22, 2019
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FNM
Product Code Name
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Public Device Record Key
54c34eb7-024f-44e7-b2a2-1e018d7c8e0f
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
June 21, 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 | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |