SHAPER No.2

GUDID 07898966433306

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

Timpel S/A

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• Primary Device ID: 07898966433306
• NIH Device Record Key: f461c818-7624-4337-a125-e29dce7e9089
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHAPER No.2
• Version Model Number: ACE-00035
• Company DUNS: 897939320
• Company Name: Timpel S/A
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07898966433306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN170072

FDA Product Code

• QEB: Ventilatory Electrical Impedance Tomograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-18
• Device Publish Date: 2021-05-10

On-Brand Devices [SHAPER No.2]

• 07898959841279: The shaper is a disposable accessory to assist the Electrode Belt to better fit the contour of t
• 07898966433306: The shaper is a disposable accessory to assist the Electrode Belt to better fit the contour of t