FDA UDI
In Commercial Distribution
🇺🇸 United States
LUMEX
DI: M368603904A1
·
Model: 603904A
·
GF HEALTH PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LUMEX
- Primary DI
- M368603904A1
- Version / Model
- 603904A
- Catalog Number
- 603904A
- Company Name
- GF HEALTH PRODUCTS, INC.
- Labeler DUNS
- 132016168
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-14
- Public Version
- 1
- Public Version Date
- 2021-07-22
- Public Version Status
- New
- Public Device Record Key
- 3bb7d5e8-74d9-4af0-8d22-3d9ef595660d
Device Description
WALKER BASKET
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
- 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 |
|---|---|---|---|---|
| INB | Attachment, Commode, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16221 | Walker tray | A metal or plastic platform designed to be attached to a wheeled walker upon which a user may place objects or perform an activity. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M368603904A1 | HIBCC |
Customer Contacts
- Phone
- 770-368-4700
- [email protected]