FDA UDI
In Commercial Distribution
🇺🇸 United States
Pixie Cup
DI: 00850016867209
·
Model: B09NQDYZMW
·
Pixie Cup LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Pixie Cup
- Primary DI
- 00850016867209
- Version / Model
- B09NQDYZMW
- Company Name
- Pixie Cup LLC
- Labeler DUNS
- 028513002
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-05
- Public Version
- 1
- Public Version Date
- 2025-11-13
- Public Version Status
- New
- Public Device Record Key
- b215c5de-8d59-4181-8b5e-d85cce587454
Device Description
Pixie Pulse - Pixie Period Pain Relief Device
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57809 | Transcutaneous blood irradiation laser | A battery-powered wearable device designed to emit low-intensity laser light (e.g., wavelength of 650 nm) for the transcutaneous irradiation of blood and tissues to improve haemodynamic and metabolic parameters (e.g., increased blood oxygen capacity and red blood cell deformability, reduced blood viscosity and blood pressure, improved blood glucose/lipids). It is intended for home-use and is typically worn on the wrist to irradiate the radial artery and NeiGuan points (medial forearm); it may include an external nasal sinus probe intended to treat rhinitis and sinusitis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850016867209 | GS1 |
Customer Contacts
- Phone
- 4172430677
- [email protected]