Duns Number:135241342
Device Description: Auto Immerssion, Alternating Rotation, Pulsation, with True Low Air Loss Universal Mattres Auto Immerssion, Alternating Rotation, Pulsation, with True Low Air Loss Universal Mattress, Standard UK System
Catalog Number
K-ZM-UK-UMS
Brand Name
K-Z Z-TURN
Version/Model Number
K-ZM-UK-UMS
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
03d565a4-8735-4aea-9bc7-e3ab36b4ec9e
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 |