Fresenius Medical Care

GUDID 04052882002883

Electric treatment chair for use in dialysis, day surgery and oncology applications designed to accommodate bariatric patients. The chair can be used for patients up to weight not exceeding 300kg ( 660 lb).

FRESENIUS MEDICAL CARE SEATING (AUSTRALIA) PTY LTD

General examination/treatment chair, electric

• Primary Device ID: 04052882002883
• NIH Device Record Key: 8a8b8bdb-036e-4bd1-90a5-550b0f41648b
• Commercial Distribution Discontinuation: 2024-08-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Fresenius Medical Care
• Version Model Number: T600B
• Company DUNS: 752905877
• Company Name: FRESENIUS MEDICAL CARE SEATING (AUSTRALIA) PTY LTD
• 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: false
• Device Combination Product: false
• Single Use: true
• 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	04052882002883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091727

FDA Product Code

• INO: Chair, Positioning, Electric

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: 2024-08-30
• Device Publish Date: 2019-08-16

On-Brand Devices [Fresenius Medical Care]

• 04052882003163: Electric Treatment chair for use in dialysis, day surgery and oncology applications. The chair i
• 04052882003651: Electric Treatment chair for use in dialysis, day surgery and oncology applications. The chair i
• 04052882002968: Manually Operated Treatment chair.
• 04052882003637: Manually Operated Treatment chair.
• 04052882003002: Electric Treatment chair for use in dialysis, day surgery and oncology applications. The chair
• 04052882002883: Electric treatment chair for use in dialysis, day surgery and oncology applications designed to