FDA UDI
In Commercial Distribution
🇺🇸 United States
Comfytopia
DI: 00767674405899
·
Model: HM1MY0-C110
·
Comfytopia, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Comfytopia
- Primary DI
- 00767674405899
- Version / Model
- HM1MY0-C110
- Company Name
- Comfytopia, Inc.
- Labeler DUNS
- 003944628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-23
- Public Version
- 1
- Public Version Date
- 2025-03-03
- Public Version Status
- New
- Public Device Record Key
- 5b6353ca-2d97-48b5-be2c-e0b4236a45ac
Device Description
HM1MY0-C110 CANE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IPS | Cane | Physical Medicine | 890.3075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31112 | Single-base walking stick | A rod, typically made of wood or metal, with one leg/foot and a handgrip or curved handle and without forearm support used to assist a person with a disability to maintain their balance and support their weight while walking. It may be of fixed or adjustable length, and collapsible or non-collapsible. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00767674405899 | GS1 |