FDA UDI
In Commercial Distribution
🇺🇸 United States
oneNEST M
DI: 00670482000777
·
Model: 303-M803508HS2FB-BIL
·
Umano Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- oneNEST M
- Primary DI
- 00670482000777
- Version / Model
- 303-M803508HS2FB-BIL
- Catalog Number
- 303-M803508HS2FB-BIL
- Company Name
- Umano Medical Inc
- Labeler DUNS
- 249675476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-21
- Public Version
- 1
- Public Version Date
- 2024-07-01
- Public Version Status
- New
- Public Device Record Key
- be8b3c86-1921-4024-8013-b0276a32a004
Device Description
303-M803508HS2FB-BIL oneNEST M is a powered mattress 80'' x 35'' 2 ways. It can be used with or without control unit.
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 |
|---|---|---|---|---|
| IOQ | Bed, Flotation Therapy, Powered | Physical Medicine | 890.5170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63641 | Alternating-pressure bed mattress | A mattress-like device consisting of an arrangement of alternating-pressure air cells designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It is connected to an alternating-pressure pump (not included) which provides the inflation/deflation control. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers) patients, patients with disabilities, or patients with low body fat. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10670482000774 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00670482000777 | GS1 |