FDA UDI
In Commercial Distribution
🇺🇸 United States
MOVE 78 Cold & Flu Kit
DI: 00850031915053
·
Model: MOVE78-ESS
·
TREND POWER LIMITED
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MOVE 78 Cold & Flu Kit
- Primary DI
- 00850031915053
- Version / Model
- MOVE78-ESS
- Company Name
- TREND POWER LIMITED
- Labeler DUNS
- 663488544
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-18
- Public Version
- 1
- Public Version Date
- 2022-01-26
- Public Version Status
- New
- Public Device Record Key
- c47ba21a-e4aa-480e-b7e7-d9629002fd26
Device Description
MOVE 78 Cold & Flu Kit comprises of a Touchless Infrared thermometer and a pulse oximeter. Both devices are bluetooth enabled.
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
- No
- 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 |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
| OCH | Oximeter, Infrared, Sporting, Aviation | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45607 | Pulse oximeter | An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers. | No | Active |
| 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 | 10850031915050 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00850031915053 | GS1 |