FDA UDI
In Commercial Distribution
🇺🇸 United States
Walgreens
DI: 00311917206721
·
Model: Bite Relief
·
WALGREEN CO.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Walgreens
- Primary DI
- 00311917206721
- Version / Model
- Bite Relief
- Company Name
- WALGREEN CO.
- Labeler DUNS
- 008965063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-21
- Public Version
- 2
- Public Version Date
- 2020-08-20
- Public Version Status
- Update
- Public Device Record Key
- e728c52d-e881-4018-be22-a959aca53311
Device Description
Piezo-electric stimulator for temporary reduction of itching and swelling resulting from mosquito bites
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
- No
- 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 |
|---|---|---|---|---|
| OSG | Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch | Neurology | 882.5894 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59437 | Insect bite/sting electrical stimulator | A portable device intended to be used for the external treatment of insect bites or stings (e.g., from mosquitoes) through dispatch of a small (e.g., 13 kV) piezeoelectric charge to the affected region of the skin. The charge is intended to localize the poison and inhibit histamine release therefore reducing itching and inflammation. It typically consists of a pocket-sized, hand-held housing containing piezocrystal with a trigger mechanism. It is available [non-prescription] over-the-counter (OTC) for home-use. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 00182097000412 | GS1 | ||||
| Primary | 00311917206721 | GS1 | ||||
| Package | 10311917206728 | GS1 | case pack | 384 | In Commercial Distribution | |
| Package | 20311917206725 | GS1 | inner pack | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-925-4733
- [email protected]