FDA UDI
In Commercial Distribution
🇺🇸 United States
AFCS PEARLS™ Traction support pole
DI: 08720387388134
·
Model: SAT2 / SAT1
·
Synergie Nederland B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AFCS PEARLS™ Traction support pole
- Primary DI
- 08720387388134
- Version / Model
- SAT2 / SAT1
- Catalog Number
- 2010317
- Company Name
- Synergie Nederland B.V.
- Labeler DUNS
- 417294923
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-20
- Public Version
- 2
- Public Version Date
- 2024-12-23
- Public Version Status
- Update
- Public Device Record Key
- d833ae5f-74fc-4f42-a5c9-6444c628b8c0
Device Description
Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) & SANDS™ (SAT1) Kit traction support pole
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
- 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 |
|---|---|---|---|---|
| INX | Bed, Air Fluidized | Physical Medicine | 890.5160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37510 | Assistive patient lifting pole | A device designed as an overhead bar with a hanging handgrip above the occupant of the bed that is attached to a medical bed or secured to the wall behind the bed and used by the occupant to provide support when changing position or pulling themselves into a sitting position. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08720387388134 | GS1 |