FDA UDI
In Commercial Distribution
🇺🇸 United States
C-Wave LED Mask for Neck & Décolleté
DI: 05060534510999
·
Model: TN2037
·
I-SMART DEVELOPMENTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- C-Wave LED Mask for Neck & Décolleté
- Primary DI
- 05060534510999
- Version / Model
- TN2037
- Company Name
- I-SMART DEVELOPMENTS LIMITED
- Labeler DUNS
- 223616320
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-11
- Public Version
- 1
- Public Version Date
- 2024-11-19
- Public Version Status
- New
- Public Device Record Key
- f3e07d88-edc1-4d0f-b062-05fd79bac473
Device Description
C-Wave LED Mask for Neck & Décolleté Beauty Pie- Rebranded Variant of TN2037 (LED Neck & Dec Device)
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
- Yes
- 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 |
|---|---|---|---|---|
| 65723 | Red/infrared light phototherapy unit | An electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060534510999 | GS1 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 32 – 86 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 55 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 23 – 131 Degrees Fahrenheit