Duns Number:688817949
Device Description: Main device 1ea, OVERLAPPING ARM SLEEVE Large(L402) 2ea, Single Hose 2ea [One set box]
Catalog Number
-
Brand Name
LF400
Version/Model Number
LF40100-OAL
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
K150033,K150033
Product Code
IRP
Product Code Name
Massager, Powered Inflatable Tube
Public Device Record Key
82d669ea-2682-420e-9473-64f1e816719e
Public Version Date
December 23, 2021
Public Version Number
1
DI Record Publish Date
December 15, 2021
Package DI Number
18809802640341
Quantity per Package
2
Contains DI Package
08809802640344
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 |