Duns Number:078821264
Device Description: Sensor Pads are intended for use with Lucerno Dynamics sensors on clean, dry, intact skin. Sensor Pads are intended for use with Lucerno Dynamics sensors on clean, dry, intact skin. The sensor side adhesive is not intended for skin contact. Factors that may impact pad performance include lotion or other skin products, patient movement, and substantial body hair.Sensor Pads consist of a double-coated, two-in-one medical grade silicone adhesive and acrylic tape. The silicone adhesive is hypoallergenic and atraumatic upon removal; it is intended for attachment to the skin. The acrylic tape is intended for attachment to the plastic case of the sensor.
Catalog Number
091220-018
Brand Name
Sensor Pad
Version/Model Number
091220-018
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
da515c18-0998-47b9-a5a9-3497916912ae
Public Version Date
September 30, 2021
Public Version Number
1
DI Record Publish Date
September 22, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-