Duns Number:135241342
Device Description: Auto Immerssion, Alternating Rotation, Pulsation, with True Low Air Loss 10" High 42" Wide Auto Immerssion, Alternating Rotation, Pulsation, with True Low Air Loss 10" High 42" Wide Mattress, Bariatric System
Catalog Number
K-ZM-B42
Brand Name
K-Z Z-TURN
Version/Model Number
K-ZM-B42
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
12ccecf1-f6ad-4c7b-aa2c-b13bac7f499d
Public Version Date
August 25, 2020
Public Version Number
1
DI Record Publish Date
August 17, 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 |