FDA UDI
In Commercial Distribution
🇺🇸 United States
Raizer
DI: 05060572010352
·
Model: M
·
THE KIRTON HEALTHCARE GROUP LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Raizer
- Primary DI
- 05060572010352
- Version / Model
- M
- Catalog Number
- 105040
- Company Name
- THE KIRTON HEALTHCARE GROUP LIMITED
- Labeler DUNS
- 291031631
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-12
- Public Version
- 1
- Public Version Date
- 2024-07-22
- Public Version Status
- New
- Public Device Record Key
- dc9cda55-a616-4fa7-93c8-0b0eb1289adf
Device Description
A manually operated device to lift a person from the floor into a seated position.
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 |
|---|---|---|---|---|
| FSA | Lift, Patient, Non-Ac-Powered | General Hospital | 880.5510 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66605 | Patient fall-recovery chair, manual | A manually-powered device designed to enable one person to lift an incapacitated or disabled patient safely and with minimal physical effort from a supine position on the floor (e.g., following a fall) to a seated position. Sometimes referred to as an emergency lifting chair, it consists of a seat with detachable legs and back supports, and a seatbelt, intended to be assembled beneath the patient like a scoop stretcher, prior to lifting them to a seated position using a manual mechanism (e.g., crank handle). It is intended for use in both the home and clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060572010352 | GS1 |