Duns Number:688817949
Device Description: Device 1ea , MXW401 2ea , Double hose 1ea, Single Hose 1ea
Catalog Number
-
Brand Name
LF900
Version/Model Number
LF90200-OMX-2
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K203019,K203019
Product Code
IRP
Product Code Name
Massager, Powered Inflatable Tube
Public Device Record Key
21341722-99fb-4277-82c3-ecead81a835e
Public Version Date
May 17, 2022
Public Version Number
1
DI Record Publish Date
May 09, 2022
Package DI Number
18809802643373
Quantity per Package
2
Contains DI Package
08809802643376
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |