FDA UDI
In Commercial Distribution
🇺🇸 United States
Well at Walgreens
DI: 00311917176390
·
Model: FDES150B Back Pads (P105B-1)
·
WALGREEN CO.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- Well at Walgreens
- Primary DI
- 00311917176390
- Version / Model
- FDES150B Back Pads (P105B-1)
- Company Name
- WALGREEN CO.
- Labeler DUNS
- 008965063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-08-16
- Public Version
- 4
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 2f339e28-1b01-4eb9-acc3-efd139b065e7
Device Description
7.48" x 3.74" gel electrodes back pads.
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
- Yes
- 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 |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35372 | Analgesic transcutaneous electrical nerve stimulation system | An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10311917176397 | GS1 | Case | 60 | Not in Commercial Distribution | 2016-10-19 |
| Primary | 00311917176390 | GS1 | ||||
| Unit of Use | 20311917176394 | GS1 |
Customer Contacts
- Phone
- 1-877-365-6274
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130723 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 27.98 | Square inch |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit