FDA UDI
In Commercial Distribution
🇺🇸 United States
Action®
DI: 00089904002198
·
Model: Mattress Overlay
·
ACTION PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Action®
- Primary DI
- 00089904002198
- Version / Model
- Mattress Overlay
- Catalog Number
- 6200
- Company Name
- ACTION PRODUCTS, INC.
- Labeler DUNS
- 067543058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-21
- Public Version
- 1
- Public Version Date
- 2021-01-29
- Public Version Status
- New
- Public Device Record Key
- 583f7ad8-3f8b-424e-ba10-0e264282abb0
Device Description
Mattress Overlay w/Cover
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 |
|---|---|---|---|---|
| IKY | Mattress, Flotation Therapy, Non-Powered | General Hospital | 880.5150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44594 | Gel-filled bed mattress overlay | A gel-filled pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00089904002198 | GS1 |
Customer Contacts
- Phone
- 301.797.1414
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in clean, dry environment
- Type
- Special Storage Condition, Specify
- Special Conditions
- Minimal UV exposure