FDA UDI
In Commercial Distribution
🇺🇸 United States
Walgreens
DI: 00311917214863
·
Model: 745309
·
WALGREEN CO.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Walgreens
- Primary DI
- 00311917214863
- Version / Model
- 745309
- Company Name
- WALGREEN CO.
- Labeler DUNS
- 008965063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-11
- Public Version
- 1
- Public Version Date
- 2020-03-19
- Public Version Status
- New
- Public Device Record Key
- a70a541b-effc-4b83-8ffe-5bb55cc78939
Device Description
WALG RED LIGHT THERAPY HANDHELD UNIT
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63381 | Musculoskeletal infrared phototherapy unit, wearable | A patient-worn, battery-powered device assembly intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., joint pain), and to improve blood circulation in these areas. It consists of a device with an integrated light with a controller; the light is intended to be attached to a specific body part (e.g., back, knee) and may include devices (e.g., adhesive pad) to allow attachment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00311917214863 | GS1 | ||||
| Package | 10311917214860 | GS1 | case | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-925-4733
- [email protected]