GETINGE 9100-SERIES 9128E-001

GUDID 07340153710061

WASHER DISINFECTOR 9128E

Getinge Disinfection AB

Surgical utensil washer/disinfector

• Primary Device ID: 07340153710061
• NIH Device Record Key: 8228e559-5830-4a43-a623-2c68e989d80b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GETINGE 9100-SERIES
• Version Model Number: 9128E
• Catalog Number: 9128E-001
• Company DUNS: 354023236
• Company Name: Getinge Disinfection AB
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340153710061 [Primary]

FDA Product Code

• MEC: Disinfector, Medical Devices

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-07-10

On-Brand Devices [GETINGE 9100-SERIES]

• 07340153710078: WASHER DISINFECTOR 9128EW
• 07340153710061: WASHER DISINFECTOR 9128E
• 07340153710054: WASHER DISINFECTOR 9127E
• 07340153710047: WASHER DISINFECTOR 9125E
• 07340153710030: WASHER DISINFECTOR 9122EW
• 07340153710023: WASHER DISINFECTOR 9120E