Primo Passi
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Basic Information
- Brand Name
- Primo Passi
- Primary DI
- 00850000125469
- Version / Model
- JPD-FR300
- Catalog Number
- SK-158
- Company Name
- Primo Passi LLC
- Labeler DUNS
- 080607433
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-27
- Public Version
- 1
- Public Version Date
- 2026-04-06
- Public Version Status
- New
- Public Device Record Key
- 42abae68-8981-4c41-b823-8235942f5867
Device Description
Primo Passi Ear and Forehead Thermometer, Model SK-158 (JPD-FR300). Electrically powered, non-contact infrared thermometer intended for the measurement of human body temperature via the ear canal or forehead. Automatically switches between ear mode and forehead mode based on probe cover position. Features passive infrared receiving technology with advanced infrared temperature sensor. Provides measurement results in approximately 1 second with a single button operation. Includes fever alert function and automatic temperature calibration. Displays temperature in Celsius or Fahrenheit. Forehead mode applicable to all age groups. Ear mode applicable to children older than 3 months, adults, and elderly. Child mode available for users under 12 years of age. Automatic power-off function. Powered by 2 AAA batteries. BPA-free materials. Single-use patient, multiple-use 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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| FLL | Continuous Measurement Thermometer | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63711 | Infrared patient thermometer, ear/skin | A hand-held, battery-powered, electronic instrument designed to measure: 1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of a site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip. This device is intended for use in the home or healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850000125469 | GS1 |
Customer Contacts
- Phone
- 888-233-3198
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131243 | 000 |