FDA UDI
In Commercial Distribution
🇺🇸 United States
Hygiene Elite - Tollos
DI: 00817956022662
·
Model: T015HF
·
1073849 Ontario Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hygiene Elite - Tollos
- Primary DI
- 00817956022662
- Version / Model
- T015HF
- Company Name
- 1073849 Ontario Limited
- Labeler DUNS
- 049181763
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-09
- Public Version
- 1
- Public Version Date
- 2022-12-19
- Public Version Status
- New
- Public Device Record Key
- 49fbb2c3-8901-445b-9b1a-6d498445004a
Device Description
Hygiene Elite Sling - Medium - Yellow Binding - 6 Loop - Tricot Material - Reuseable
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
- 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 |
|---|---|---|---|---|
| FSA | Lift, Patient, Non-Ac-Powered | General Hospital | 880.5510 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33476 | Patient lifting system divided leg sling | A lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position with their legs held apart and posterior exposed for toileting and washing. It is typically designed as a U-shaped sling construction made of strengthened fabric with lifting straps, a back support with or without head support and individual leg straps (bands) that are wrapped around each leg to support the patient/person in a sitting position with divided legs. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817956022662 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 18 | Inch | |
| Width | 12 | Inch | |
| Depth | 4 | Inch |