FDA UDI
In Commercial Distribution
🇺🇸 United States
Fresenius Medical Care
DI: 04052882003002
·
Model: T688
·
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
- 04052882003002
- Version / Model
- T688
- 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
- 4f0f9e84-7935-4434-8c1c-c604d37a1a1a
- Distribution End Date
- 2024-08-30
Device Description
Electric Treatment chair for use in dialysis, day surgery and oncology applications. The chair is intended for patients with weight not exceeding 440 lbs (200kg)
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 | 04052882003002 | GS1 |