FDA UDI
In Commercial Distribution
🇺🇸 United States
Action®
DI: 00089904006011
·
Model: Wheelchair Cushion Cover
·
ACTION PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Action®
- Primary DI
- 00089904006011
- Version / Model
- Wheelchair Cushion Cover
- Catalog Number
- COS5108
- Company Name
- ACTION PRODUCTS, INC.
- Labeler DUNS
- 067543058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-02
- Public Version
- 1
- Public Version Date
- 2021-02-10
- Public Version Status
- New
- Public Device Record Key
- 0b5b9c52-4397-4b98-a65c-d9a0b7699e87
Device Description
Super Lo Shear Cover - Professional™
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| KNN | Components, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62720 | Medical cushion cover | A device intended to cover a medical cushion (e.g., birthing cushion, lumbar cushion, wheelchair cushion) during use to protect the cushion from dirt/debris to maintain hygiene. It may be dedicated to a specific type of cushion or non-dedicated; it is not intended for surgical use and is not intended to cover a pillow primarily used in bed. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00089904006011 | GS1 |
Customer Contacts
- Phone
- 301.797.1414
- [email protected]