Duns Number:135241342
Device Description: Auto Immerssion,Rotation, Alternating Pressure with On-Demand Low Air Loss 36"~42"~48" Wid Auto Immerssion,Rotation, Alternating Pressure with On-Demand Low Air Loss 36"~42"~48" Wide, 80"~85"~90" Long Expandable Mattress, Bariatric System
Catalog Number
K-6ST-XMS
Brand Name
K-6 TURN-ZONE
Version/Model Number
K-6ST-XMS
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKZ
Product Code Name
Bed, Patient Rotation, Powered
Public Device Record Key
5e7536b4-9d2d-456f-96e7-d447d7d00848
Public Version Date
September 21, 2020
Public Version Number
1
DI Record Publish Date
September 11, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1029 |