FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 10885632118937
·
Model: MCFR359P
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 10885632118937
- Version / Model
- MCFR359P
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-05
- Public Version
- 1
- Public Version Date
- 2020-10-13
- Public Version Status
- New
- Public Device Record Key
- 529ce22e-a4b4-4687-8705-22f6cc0cefe7
Device Description
Chair Treatment Power Recline Economy Fire Rated 3 Inch Steel Caster 300 Pound Capacity Steel Frame Not Made With Natural Rubber Latex MediChoice
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
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| GBB | CHAIR, SURGICAL, AC-POWERED | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58419 | Mobile bariatric examination/treatment chair, electric | A mobile (on wheels) electronic device designed to support in a seated position an ambulatory or non-ambulatory bariatric (obese) patient, whose body mass exceeds the safe working load of a standard hospital/institution chair (e.g., around 350 kg), for examination/treatment. It incorporates a heavy-duty framework, extra wide seat-support for the patient, and an integrated rechargeable battery pack that powers electromotive functions (e.g., raise/lower/tilt/adjustment functions, motorized wheels). It is designed to be moved by healthcare professional for patient transport to a site for patient support without transfer during outpatient examination/treatment (e.g., surgical, dental, ENT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10885632118937 | GS1 |