AccessGUDID - DEVICE: SHAPER No.2 (07898959841279)

GUDID

Device Identifier (DI) Information

Brand Name: SHAPER No.2
Version or Model: AD-05002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Timpel S/A

Primary DI Number: 07898959841279
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 897939320 *Terms of Use

Device Description: The shaper is a disposable accessory to assist the Electrode Belt to better fit the contour of the patient's chest, if needed. Available in two sizes, biocompatible, non-invasive, non-sterile and not to be sterilized

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?
64407	Electrical impedance skin electrode chest positioner	A device designed to be adhered to a patient’s thoracic region to aid in the correct placement and positioning of cutaneous electrodes during breast electrical impedance (bioimpedance) spectroscopy [EIS/BIS], thoracic tomography (EIT) or segmentography procedures. It is available in various shapes (e.g., skin-adhesive star, belt) designed to better fit the contours of a patient’s chest and/or breast. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QEB	Ventilatory Electrical Impedance Tomograph

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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 -10 and 55 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 305405d4-e039-40fd-84d3-b6f8025af343
Public Version Date: February 06, 2025
Public Version Number: 5
DI Record Publish Date: October 28, 2019