FDA UDI
In Commercial Distribution
🇺🇸 United States
ELEVATE BY ARMEDICA
DI: B866MELE3B1
·
Model: ELE3B
·
ARMEDICA MANUFACTURING CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ELEVATE BY ARMEDICA
- Primary DI
- B866MELE3B1
- Version / Model
- ELE3B
- Catalog Number
- ELE3B
- Company Name
- ARMEDICA MANUFACTURING CORP.
- Labeler DUNS
- 018941711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-18
- Public Version
- 1
- Public Version Date
- 2022-11-28
- Public Version Status
- New
- Public Device Record Key
- be40efe3-8266-4ae7-9a23-19aed4e31edc
Device Description
BLACK STEEL FRAME, ELECTRIC, BAR ACTIVATED, THREE SECTION, 27 IN WIDE TREATMENT TABLE WITH ADJUSTABLE HEAD SECTION, FIXED CENTER SECTION, ADJUSTABLE FOOT SECTION, SIDE PANELS, AND CASTERS.
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| INQ | Table, Powered | Physical Medicine | 890.3760 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31362 | Examination/treatment table, line-powered | A mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B866PELE3B1 | HIBCC | SKID | 1 | In Commercial Distribution | |
| Primary | B866MELE3B1 | HIBCC |