SHAPER No.2

Basic Information

• Brand Name: SHAPER No.2
• Primary DI: 07898966433306
• Version / Model: ACE-00035
• Company Name: Timpel S/A
• Labeler DUNS: 897939320
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-10
• Public Version: 3
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: f461c818-7624-4337-a125-e29dce7e9089

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QEB	Ventilatory Electrical Impedance Tomograph	Anesthesiology	868.1505	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64407	Thoracic electrical impedance electrode array positioner	A device designed to be attached to an adhesive belt-like electrode array to enable it to better fit the contours of a patient’s chest during thoracic electrical impedance (bioimpedance) tomography (EIT) or segmentography. It has a half-moon shape and is made of synthetic polymer materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07898966433306	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN170072	000