Duns Number:355804758
Device Description: Skin IQ Microclimate Manager - Mattress Coverlet Power Supply Only, 4 Pack
Catalog Number
-
Brand Name
SKIN IQ
Version/Model Number
SIQPSST04UC
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
Yes
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
IOQ
Product Code Name
BED, FLOTATION THERAPY, POWERED
Public Device Record Key
d4218d36-e5bc-4ef7-a34b-5b691ba5b7cd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 01, 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 |