FDA UDI
In Commercial Distribution
🇺🇸 United States
Repose Mattress Overlay
DI: 05056279301152
·
Model: 6011100
·
Frontier Therapeutics Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Repose Mattress Overlay
- Primary DI
- 05056279301152
- Version / Model
- 6011100
- Catalog Number
- 6011100
- Company Name
- Frontier Therapeutics Inc
- Labeler DUNS
- 111598708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-25
- Public Version
- 1
- Public Version Date
- 2021-04-02
- Public Version Status
- New
- Public Device Record Key
- cc07a1d9-27a1-44d9-8179-295c2d500b06
Device Description
Repose Mattress Overlay is designed for use on a standard single mattress, where it is proven to provide effective pressure redistribution. Suitable for use in both acute and community settings, Repose Mattress Overlay comes packaged inside a unique and easy to use pump, which enables the mattress overlay to be inflated ready for use within seconds, and the smart valve ensures that the product is inflated to the optimal pressure.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| IKY | Mattress, Flotation Therapy, Non-Powered | General Hospital | 880.5150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47476 | Air-filled bed mattress overlay | A static-air-inflated 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 | 05056279301152 | GS1 |