Oscilla

GUDID 57135570000003

Inmedico A/S

Tone audiometer, automated

• Primary Device ID: 57135570000003
• NIH Device Record Key: bdab0b97-1a99-410c-9bd3-16202cffb3e5
• Commercial Distribution Discontinuation: 2017-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Oscilla
• Version Model Number: SM920-P
• Company DUNS: 305698078
• Company Name: Inmedico A/S
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4586742622
• Email: support@oscillahearing.com
• Phone: +4586742622
• Email: support@oscillahearing.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 120 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 120 KiloPascal
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	57135570000003 [Primary]

FDA Product Code

• EWO: Audiometer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-05-24
• Device Publish Date: 2016-09-21

On-Brand Devices [Oscilla]

• 57135570000012: USB350-SP
• 57135570000011: USB350-B
• 57135570000010: USB330
• 57135570000009: USB310
• 57135570000008: SM450-FF
• 57135570000007: SM960-C
• 57135570000006: SM950-S
• 57135570000005: SM950
• 57135570000004: SM930
• 57135570000003: SM920-P
• 57135570000002: SM910-B
• 57135570000001: SM910
• 57135570000124: USB350-SP
• 57135570000117: USB350-B
• 57135570000100: USB330
• 57135570000094: USB310
• 57135570000087: SM450-FF
• 57135570000070: SM960-C
• 57135570000063: SM950-S
• 57135570000056: SM950
• 57135570000049: SM930
• 57135570000032: SM920-P
• 57135570000025: SM910-B
• 05713557000120: USB350-SP
• 05713557000113: USB350-B
• 05713557000106: USB330
• 05713557000090: USB310
• 05713557000083: SM450-FF
• 05713557000076: SM960-C
• 05713557000069: SM950-S
• 05713557000052: SM950
• 05713557000045: SM930
• 05713557000038: SM920-P
• 05713557000021: SM910-B
• 05713557000014: SM910