FDA UDI
Not in Commercial Distribution
🇺🇸 United States
VELA Rumba
DI: 05714339123358
·
Model: 87215 Treatment chair
·
Vermund Larsen A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VELA Rumba
- Primary DI
- 05714339123358
- Version / Model
- 87215 Treatment chair
- Company Name
- Vermund Larsen A/S
- Labeler DUNS
- 305793176
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-10
- Public Version
- 1
- Public Version Date
- 2025-06-18
- Public Version Status
- New
- Public Device Record Key
- 86ab7df4-68fc-4083-a34d-bd04c50a3e00
- Distribution End Date
- 2025-06-10
Device Description
Treatment chair for adult people
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 |
|---|---|---|---|---|
| INM | Chair, With Casters | Physical Medicine | 890.3100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47117 | Haemodialysis chair, electric | A mains electricity (AC-powered) device designed to support the patient in a seated or reclined posture during haemodialysis procedures. It is usually made of easily washable materials, with appropriate arm, back, and footrests that can be adjusted by the patient using a powered mechanism. It provides interface with the dialysis system, facilitating the patient connection to the extracorporeal blood circuit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05714339123358 | GS1 |