FDA UDI
In Commercial Distribution
🇺🇸 United States
Star
DI: 07320450170898
·
Model: Standard Air Cushion
·
Etac Supply Center AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Star
- Primary DI
- 07320450170898
- Version / Model
- Standard Air Cushion
- Catalog Number
- ESSCS1113-1IC
- Company Name
- Etac Supply Center AB
- Labeler DUNS
- 354870610
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- 266c995a-d1f5-4eb9-9a1b-f339c56164d8
Device Description
11.75 x 13.5 x 2 IC
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 |
|---|---|---|---|---|
| IMP | CUSHION, WHEELCHAIR | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47477 | Air-filled chair cushion | A static-air-inflated pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07320450170898 | GS1 |