Duns Number:084527241
Device Description: Fits the Mizuho OSI model 6300-8 Patient Transfer Board. Made with Tempur-Pedic® Medical m Fits the Mizuho OSI model 6300-8 Patient Transfer Board. Made with Tempur-Pedic® Medical materials.
Catalog Number
6300-7321
Brand Name
ASSY, TRANSFER PAD
Version/Model Number
6300-7321
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"
Yes
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
FMP
Product Code Name
Protector, Skin Pressure
Public Device Record Key
e7909903-0e07-4efc-9ab7-df9145ed407d
Public Version Date
November 19, 2020
Public Version Number
3
DI Record Publish Date
May 10, 2017
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 | 1076 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |