FDA UDI
In Commercial Distribution
🇺🇸 United States
ADJUSTER 12 O2 14x18x5"
DI: 08717261065656
·
Model: OAD12/3545
·
Vicair B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ADJUSTER 12 O2 14x18x5"
- Primary DI
- 08717261065656
- Version / Model
- OAD12/3545
- Company Name
- Vicair B.V.
- Labeler DUNS
- 416605657
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-14
- Public Version
- 1
- Public Version Date
- 2023-12-22
- Public Version Status
- New
- Public Device Record Key
- 2c07650a-1ca4-43fa-8f27-1a26a1d66ec4
Device Description
Wheelchair cushion
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
- 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 |
|---|---|---|---|---|
| IMP | CUSHION, WHEELCHAIR | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11100 | Wheelchair seat cushion | A padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717261065656 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 14 | Inch | |
| Depth | 18 | Inch | |
| Device Size Text, specify |