Biopor® AB Xtreme 288420M

GUDID E239288420M1

No.

Dreve Otoplastik GmbH

Earmould, custom-made

• Primary Device ID: E239288420M1
• NIH Device Record Key: e6a19377-7527-493d-bb42-859d96aac01f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biopor® AB Xtreme
• Version Model Number: 288420M
• Catalog Number: 288420M
• Company DUNS: 315808340
• Company Name: Dreve Otoplastik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239288420M1 [Primary]

FDA Product Code

• ESD: Hearing aid, air conduction

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: 2022-08-26
• Device Publish Date: 2022-08-18

On-Brand Devices [Biopor® AB Xtreme]

• E2392886621: No.
• E239288652M1: No.
• E2392886521: No.
• E239288642M1: No.
• E2392886421: No.
• E239288634M1: No.
• E2392886341: No.
• E2392886321: No.
• E2392886221: No.
• E23928861M1: No.
• E239288618M1: No.
• E2392886181: No.
• E239288617M1: No.
• E2392886171: No.
• E239288613M1: No.
• E2392886131: No.
• E239288611: No.
• E23928860M1: No.
• E239288601: No.
• E23928844M1: No.
• E239288441: No.
• E2392884301: No.
• E23928842M1: No.
• E239288428M1: No.
• E2392884281: No.
• E239288427M1: No.
• E2392884271: No.
• E239288426M1: No.
• E2392884261: No.
• E239288425M1: No.
• E2392884251: No.
• E239288424M1: No.
• E2392884241: No.
• E239288423M1: No.
• E2392884231: No.
• E2392884221: No.
• E239288421M1: No.
• E2392884211: No.
• E239288421: No.
• E239288420M1: No.
• E2392884201: No.
• E23928841M1: No.
• E239288418M1: No.
• E2392884181: No.
• E239288417M1: No.
• E2392884171: No.
• E239288416M1: No.
• E2392884161: No.
• E239288415M1: No.
• E2392884151: No.