FDA UDI
In Commercial Distribution
🇺🇸 United States
KLYO
DI: B773KHSTR0
·
Model: KHSTR
·
KLYO MEDICAL SYSTEMS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KLYO
- Primary DI
- B773KHSTR0
- Version / Model
- KHSTR
- Company Name
- KLYO MEDICAL SYSTEMS INC.
- Labeler DUNS
- 058639417
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-23
- Public Version
- 1
- Public Version Date
- 2024-03-04
- Public Version Status
- New
- Public Device Record Key
- 4ae54299-585c-4adc-8581-97a4836946b0
Device Description
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.
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 |
|---|---|---|---|---|
| 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 | B773KHSTR0 | HIBCC |
Customer Contacts
- Phone
- 3053305025
- [email protected]