Duns Number:688817949
Device Description: LX7 set : Sequential Compression Pump with 2 Leg Sleeves(XXL Size), 1 Double Hose
Catalog Number
-
Brand Name
Compressible Limb Therapy System
Version/Model Number
Dsg0443XXL
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
K102320,K102320
Product Code
IRP
Product Code Name
Massager, Powered Inflatable Tube
Public Device Record Key
c663cf3a-1587-4499-8a81-c55018628292
Public Version Date
February 18, 2019
Public Version Number
1
DI Record Publish Date
January 16, 2019
Package DI Number
28809315678944
Quantity per Package
2
Contains DI Package
18809315678947
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 |