FDA UDI
In Commercial Distribution
🇺🇸 United States
AFCS PEARLS™ Control unit
DI: 08720387388004
·
Model: SAT2
·
Synergie Nederland B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AFCS PEARLS™ Control unit
- Primary DI
- 08720387388004
- Version / Model
- SAT2
- Catalog Number
- 2010002-US
- 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
- 1
- Public Version Date
- 2021-08-30
- Public Version Status
- New
- Public Device Record Key
- 3df98db1-c1b6-4e62-b19b-1636a11a4d7f
Device Description
Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Innovative care Control Unit
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 |
|---|---|---|---|---|
| INX | Bed, Air Fluidized | Physical Medicine | 890.5160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35921 | Air-fluidized bed | A mains electricity (AC-powered) bed designed for the treatment of severely and extensively burned patients. It may also be used in cases of decubitus ulcers or where the patient has little remaining body fat (extreme anorexia) and the displacement of the body weight is vital. It employs the circulation of filtered and temperature-regulated air forced through large quantities of ceramic spherules (small round beads) which become transformed from a solid mass into an almost liquid (fluidized) state, providing the patient with complete uplift over the whole supine body surface. Other beneficial effects are the drying of wound seepage and reduction of infection risk. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08720387388004 | GS1 |