FDA UDI
In Commercial Distribution
🇺🇸 United States
MERITS
DI: 04714379291964
·
Model: H101U-CPMU
·
MERITS HEALTH PRODUCTS CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MERITS
- Primary DI
- 04714379291964
- Version / Model
- H101U-CPMU
- Company Name
- MERITS HEALTH PRODUCTS CO., LTD.
- Labeler DUNS
- 657231924
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-08
- Public Version
- 1
- Public Version Date
- 2019-07-16
- Public Version Status
- New
- Public Device Record Key
- a01e9089-d05e-42cc-98c9-eb06e3451fa2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| 40538 | Manual patient lifting belt/harness | A device used to assist healthcare professionals or attending persons to physically move and lift a patient or a person with a disability (e.g., from the floor to a bed). The device is typically made strong textile materials (e.g., nylon or canvas) consisting of belts/harnesses. The device will typically require two persons to safely perform the lift. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04714379291964 | GS1 |