FDA UDI
In Commercial Distribution
🇺🇸 United States
Probasics
DI: 00815067071234
·
Model: CNQHLBB
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Probasics
- Primary DI
- 00815067071234
- Version / Model
- CNQHLBB
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 2
- Public Version Date
- 2023-09-06
- Public Version Status
- Update
- Public Device Record Key
- 1b1a91ef-e4ab-4bd4-a205-0397f2e756ac
Device Description
ProBasics Bariatric Large Base Quad Cane
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IPS | Cane | Physical Medicine | 890.3075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17631 | Single-side-support walking frame | A mobility aid in the form of a waist-high framework and a handgrip with two legs designed to provide a stable support to only one side of the user, e.g., a person with a disability, a geriatric or an infirm person; it may also be used during rehabilitation. It is typically constructed of lightweight metal, plastic and rubber materials in the shape of an "A" or and inverted "U" frame with a cross-strut or struts that keep the two feet apart providing stable contact with the ground. It is held by the user's hand to provide an optional form of support for standing and ambulating for a user needing more support than that provided by a walking stick (a cane) and who do not require a crutch. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30815067071235 | GS1 | CARTON | 2 | In Commercial Distribution | |
| Primary | 00815067071234 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]