AccessGUDID - DEVICE: 9Line (G096R929220)

GUDID

Device Identifier (DI) Information

Brand Name: 9Line
Version or Model: R-92922
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R-92922
Company Name: Rising Eagle Medical LLC

Primary DI Number: G096R929220
Issuing Agency: HIBCC
Commercial Distribution End Date: June 28, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 080145608 *Terms of Use

Device Description: Disposable CardiPatch, skin patch over pacemaker site cushion (1 Case of 6 boxes. Each box contains 2 patches)

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):	No
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?
66981	Pacemaker site protection skin-adherent pad	A skin-adherent device intended to be applied to chest skin over the pocket of an implantable cardiac device (e.g., pacemaker) to protect the area from impact/injury during the recipient’s daily activities. It is in the form of an adhesive cushioned pad made of spongy materials (e.g., foam, gel). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMP	Protector, Skin Pressure

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba97cd53-7634-4f97-abae-79112f29c4c3
Public Version Date: October 07, 2024
Public Version Number: 2
DI Record Publish Date: January 30, 2024