FDA UDI
In Commercial Distribution
🇺🇸 United States
ONE-CARE Non-Contact Infrared Thermometer
DI: 00810008217986
·
Model: 4020 ONE-CARE Non-Contact Infrared Thermometer HTD8813C
·
MediVena, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- ONE-CARE Non-Contact Infrared Thermometer
- Primary DI
- 00810008217986
- Version / Model
- 4020 ONE-CARE Non-Contact Infrared Thermometer HTD8813C
- Catalog Number
- 4020
- Company Name
- MediVena, LLC
- Labeler DUNS
- 080740980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-20
- Public Version
- 2
- Public Version Date
- 2024-11-25
- Public Version Status
- Update
- Public Device Record Key
- 68054441-9ad2-49d9-b765-9ba7255307ce
Device Description
The ONE-CARE Non-Contact Infrared Thermometer HTD8813C is a battery-operated, non-contact infrared thermometer with two modes for multi-measurement: body mode for measuring forehead temperature and surface mode for measuring the temperature of objects such as rooms, milk, food, water, etc.
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
- Yes
- 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 |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17888 | Infrared patient thermometer, skin | A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810008217993 | GS1 | Case | 40 | In Commercial Distribution | |
| Primary | 00810008217986 | GS1 |
Customer Contacts
- Phone
- 4045142586
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 138 | Millimeter | |
| Width | 95 | Millimeter | |
| Height | 40 | Millimeter |