FDA UDI
In Commercial Distribution
🇺🇸 United States
Selectis
DI: B572116000
·
Model: 11600
·
EMERALD SUPPLIES INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Selectis
- Primary DI
- B572116000
- Version / Model
- 11600
- Company Name
- EMERALD SUPPLIES INC
- Labeler DUNS
- 080689611
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-26
- Public Version
- 1
- Public Version Date
- 2020-03-05
- Public Version Status
- New
- Public Device Record Key
- 7aa2c18d-0d19-41d9-8e66-58bf1e45b489
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 |
|---|---|---|---|---|
| KIC | Cushion, Flotation | Physical Medicine | 890.3175 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64320 | Air-filled chair cushion, dynamic | An electrically-powered, air-inflated arrangement of cushions and supports intended to be attached to a chair (e.g., wheelchair, dining chair) to provide comfort, improve posture, and help prevent pressure sores for the occupant, who is typically a patient affected by neuromuscular dysfunction. The device is composed of different cushions (e.g., lumbar, pelvic) which are independently inflated/deflated by an attendant and/or the occupant via electronic controls; the device may feature automatic inflation/deflation with occupant movement. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B572116000 | HIBCC |