AccessGUDID - DEVICE: Sensor Pad (00850014578145)

GUDID

Device Identifier (DI) Information

Brand Name: Sensor Pad
Version or Model: 091220-018
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 091220-018
Company Name: LUCERNO DYNAMICS, LLC

Primary DI Number: 00850014578145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 078821264 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34831	Hypoallergenic skin adhesive tape	A flexible band of fabric, plastic, paper, or other material, coated on one side with a pressure-sensitive adhesive, and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic), intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter); it is not waterproof. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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