AccessGUDID - DEVICE: Fresenius Medical Care (04052882002883)

GUDID

Device Identifier (DI) Information

Brand Name: Fresenius Medical Care
Version or Model: T600B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: FRESENIUS MEDICAL CARE SEATING (AUSTRALIA) PTY LTD

Primary DI Number: 04052882002883
Issuing Agency: GS1
Commercial Distribution End Date: August 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 752905877 *Terms of Use

Device Description: 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).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38447	General examination/treatment chair, electric	A mains electricity (AC-powered) device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms; it may have an integrated weighing scale. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INO	Chair, Positioning, Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091727	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8a8b8bdb-036e-4bd1-90a5-550b0f41648b
Public Version Date: August 30, 2024
Public Version Number: 2
DI Record Publish Date: August 16, 2019