QScreen Set

GUDID 04260223146336

Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 101023 EP-LT P/N 100860 Insert Earphone PATH P/N 101205 Electrode cable with mini clips P/N 100337-QScreen FW ABR Quick P/N 100424-QScreen FW Binaural ABR P/N 100110-QScreen FW DPOAE P/N 100536-QScreen FW FMDPOAE P/N 100109-QScreen FW TEOAE P/N 100414-QScreen FW Labelprinter P/N 101043 Accessory box EP-LT (AB-LT01) P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual English

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223146336
• NIH Device Record Key: 9bf7023e-3d33-47c6-a40a-1afa31174441
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QScreen Set
• Version Model Number: 101275-T-D-A-IP
• Company DUNS: 551540334
• Company Name: PATH medical GmbH
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	04260223146336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220139

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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: 2023-05-29
• Device Publish Date: 2023-05-19

On-Brand Devices [QScreen Set]

• 04260223145889: Set consisting of: P/N 101249 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station
• 04260223146725: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146688: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146671: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146664: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146657: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146565: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146558: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146541: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146534: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146343: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146336: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146329: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146312: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146305: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146299: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146282: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146275: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146268: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223146251: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223147302: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223147296: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223147289: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do
• 04260223147272: Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Do