Duns Number:355804758
Device Description: Mattress - Alternating Pressure - Auto Logic 175 (Reliant IS) Length 2030mm (80"), Width 8 Mattress - Alternating Pressure - Auto Logic 175 (Reliant IS) Length 2030mm (80"), Width 860mm (34"), Height 175mm (7")
Catalog Number
-
Brand Name
AUTOLOGIC
Version/Model Number
PXB005DAR
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
FNM
Product Code Name
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Public Device Record Key
9fe8def3-7a9f-41a1-9d36-757fa9f74897
Public Version Date
March 29, 2018
Public Version Number
2
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 420 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 840 |