FDA UDI
In Commercial Distribution
🇺🇸 United States
BOUNDER Plus
DI: 00861980000493
·
Model: Power Gurney
·
21ST CENTURY SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BOUNDER Plus
- Primary DI
- 00861980000493
- Version / Model
- Power Gurney
- Company Name
- 21ST CENTURY SCIENTIFIC, INC.
- Labeler DUNS
- 099447922
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-12
- Public Version
- 1
- Public Version Date
- 2023-06-20
- Public Version Status
- New
- Public Device Record Key
- 5c5cdc65-6668-41a2-b284-dd1d5b916e24
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 |
|---|---|---|---|---|
| INK | Stretcher, Wheeled, Powered | Physical Medicine | 890.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33000 | Hospital stretcher, powered | A battery-powered mobile platform designed to transport a recumbent patient within a healthcare facility (e.g., to and from beds, chairs, treatment facilities, wheelchairs, and transportation vehicles). It typically includes a fixed, wheeled undercarriage, batteries, electric motor(s), and steering/operative controls. Some types, when fitted with a radiolucent surface, may be used for the acquisition of radiographic images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00861980000493 | GS1 |