FDA UDI
In Commercial Distribution
🇺🇸 United States
Fresenius Medical Care
DI: 04052882002883
·
Model: T600B
·
FRESENIUS MEDICAL CARE SEATING (AUSTRALIA) PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fresenius Medical Care
- Primary DI
- 04052882002883
- Version / Model
- T600B
- Company Name
- FRESENIUS MEDICAL CARE SEATING (AUSTRALIA) PTY LTD
- Labeler DUNS
- 752905877
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-16
- Public Version
- 1
- Public Version Date
- 2019-08-26
- Public Version Status
- New
- Public Device Record Key
- 8a8b8bdb-036e-4bd1-90a5-550b0f41648b
- Distribution End Date
- 2024-08-30
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
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| INO | Chair, Positioning, Electric | Physical Medicine | 890.3110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04052882002883 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091727 | 000 |