FDA UDI
In Commercial Distribution
🇺🇸 United States
Handicare
DI: 00810045514840
·
Model: 600084
·
HANDICARE USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Handicare
- Primary DI
- 00810045514840
- Version / Model
- 600084
- Company Name
- HANDICARE USA, INC.
- Labeler DUNS
- 800145836
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-09
- Public Version
- 3
- Public Version Date
- 2024-09-17
- Public Version Status
- Update
- Public Device Record Key
- 40894a18-93fb-4acb-b3d6-c16f8f0be895
Device Description
Extra Large Disposable Belt
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| INE | Sling, Overhead Suspension, Wheelchair | Physical Medicine | 890.3910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45382 | Stand-up mobile patient lifting system sling/harness | A lifting device used together with a stand-up mobile lift system to provide a support for an incapacitated patient or a person with a disability that is being lifted from a sitting to a standing position for transfer, (re)positioning and use of a toilet. It is also used to support the patient/person in a standing position to assist in dressing them. It is designed as a sling/harness construction made of straps which is strapped around the person's chest and which will cradle and hold their body during the lifting process. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810045514840 | GS1 | ||||
| Package | 00810045517100 | GS1 | Case | 10 | In Commercial Distribution |