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

Thoracic electrical bioimpedance system electrode array positioner
Primary Device ID07898966433306
NIH Device Record Keyf461c818-7624-4337-a125-e29dce7e9089
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHAPER No.2
Version Model NumberACE-00035
Company DUNS897939320
Company NameTimpel S/A
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107898966433306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEBVentilatory Electrical Impedance Tomograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-18
Device Publish Date2021-05-10

On-Brand Devices [SHAPER No.2]

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

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