FDA UDI
In Commercial Distribution
🇺🇸 United States
I-MED Non-Contact Infrared digital Clinical Thermometer
DI: 00622554057004
·
Model: 5700
·
I-Med Pharma Inc
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- I-MED Non-Contact Infrared digital Clinical Thermometer
- Primary DI
- 00622554057004
- Version / Model
- 5700
- Catalog Number
- 5700
- Company Name
- I-Med Pharma Inc
- Labeler DUNS
- 249008772
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-18
- Public Version
- 3
- Public Version Date
- 2022-10-05
- Public Version Status
- Update
- Public Device Record Key
- cf5ac084-d8cf-4455-81de-c703fd63d45c
Device Description
Ideal for quickly detecting elevated body temperature using a non-contact design. Measures body temperature from 90°F to 109°F (32.0°C to 42.5°C) without contact. Accurate to 0.5°F (0.3°C) with 0.1°F/°C resolution. Adjustable alarm alerts user visually and audibly when temperature exceeds programmed limit. Optimum measurement distance of 2 in. to 5.9-in. (5 to 15 cm).
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| FQZ | THERMOMETER, CLINICAL COLOR CHANGE | General Hospital | 880.2900 | 1 |
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00622554057004 | GS1 |
Customer Contacts
- Phone
- +1(514)758-9998
- [email protected]