FDA UDI
In Commercial Distribution
🇺🇸 United States
Hugo
DI: 07540212108932
·
Model: 700-961
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hugo
- Primary DI
- 07540212108932
- Version / Model
- 700-961
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-03
- Public Version
- 4
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 56134ae2-e378-49ce-b0e3-e57e09bc8278
Device Description
Hugo Elite Roll KD, Red, 1EA, 2CV, Ret.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| ITJ | WALKER, MECHANICAL | Physical Medicine | 890.3825 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31119 | Handgrip disability-assistive walker, non-powered, non-foldable | A non-powered, all- or partially-wheeled mobility aid in the form of a waist- or trunk-high, non-foldable framework with handgrips or hand-held frame and three or four legs, designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient when standing or ambulating; it might be used for rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials in the shape of a mobile support structure which the patient holds and pushes in front of them as they walk. It is non-foldable and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540212108932 | GS1 |