FDA UDI
In Commercial Distribution
🇺🇸 United States
The Freedom Bed
DI: B414PAR3A2F0
·
Model: PAR3-A2F
·
ProBed Medical Technologies Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- The Freedom Bed
- Primary DI
- B414PAR3A2F0
- Version / Model
- PAR3-A2F
- Company Name
- ProBed Medical Technologies Inc
- Labeler DUNS
- 254965734
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-25
- Public Version
- 3
- Public Version Date
- 2019-04-19
- Public Version Status
- Update
- Public Device Record Key
- 98062780-0c8d-4093-b8c8-c1e08c8b7562
Device Description
Base Model with rotation + Add air powered head and leg elevations
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| IKZ | Bed, Patient Rotation, Powered | Physical Medicine | 890.5225 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37007 | Kinetic bed | A mains electricity (AC-powered) bed designed to enable continuous change of the patient's lying position, e.g., it can tilt the entire bed mattress support system (this includes the mattress, the framework that supports the mattress, and the bedding) lengthways, sideways or to a near vertical tilt; the patient will be secured in such extreme position. The bed is used for the treatment of critically ill patients who are immobilized, often during ventilator treatment, in order to prevent oedema, improve circulation, and prevent bedsores; it is also used for patients with severe back problems. It may have an integrated weighing scale. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B414PAR3A2F0 | HIBCC |
Customer Contacts
- Phone
- 604-852-3096
- [email protected]