FDA UDI
In Commercial Distribution
🇺🇸 United States
heat it classic USB-C
DI: 04262370293031
·
Model: 010_00575-4
·
Kamedi GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- heat it classic USB-C
- Primary DI
- 04262370293031
- Version / Model
- 010_00575-4
- Company Name
- Kamedi GmbH
- Labeler DUNS
- 315161593
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-23
- Public Version
- 1
- Public Version Date
- 2024-05-01
- Public Version Status
- New
- Public Device Record Key
- 63e95f91-24cf-4eca-8bf4-24dd701e40c3
Device Description
Smartphone add-on for the symptomatic treatment of insect bites with heat.
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
- 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 |
|---|---|---|---|---|
| IRT | Pad, Heating, Powered | Physical Medicine | 890.5740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47103 | Insect bite/sting hyperthermia device | A portable, electrically-powered device intended to be used for the external surface treatment of insect bites or stings (e.g., from midges/gnats, mosquitoes, wasps, hornets, horseflies) through the topical application of concentrated heat. The heat (around 50° Celsius) works to minimize or prevent itching, and may prevent subsequent swelling. It may be either a self-contained hand-held unit or an attachment for a smartphone. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04262370293031 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -13 – 158 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 41 – 104 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- 70 – 106 KiloPascal