FDA UDI
In Commercial Distribution
🇺🇸 United States
BOUNDER Plus
DI: 00861980000486
·
Model: Manual Gurney
·
21ST CENTURY SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BOUNDER Plus
- Primary DI
- 00861980000486
- Version / Model
- Manual 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
- 2023-06-11
- Public Version
- 1
- Public Version Date
- 2023-06-19
- Public Version Status
- New
- Public Device Record Key
- e567c169-ac02-4340-8ecd-5abcaee091b8
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 |
|---|---|---|---|---|
| FPO | Stretcher, Wheeled | General Hospital | 880.6910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38052 | Assistive wheeled stretcher | A manually-operated device designed as a wheeled stretcher with a platform made for a person with a disability in a lying position to transport themselves around. It has a flat top surface upon which the user lies on their stomach and four wheels. It is available in a variety of designs, e.g., having two large hand-propelled wheelchair type wheels at the front which also provides a steering capability, or it can be very low so that the user propels and steers by pushing directly on the floor. It will provide a person with a disability with a means of limited mobility typically without presence of an attendant. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00861980000486 | GS1 |