OCCObaby
Basic Information
- Brand Name
- OCCObaby
- Primary DI
- 00863101000320
- Version / Model
- OCCOscan OCCOflex Bundle
- Company Name
- DEOCCO LLC
- Labeler DUNS
- 080378236
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2021-10-18
- Public Version Status
- Update
- Public Device Record Key
- ed73ec66-0d8a-4980-97ce-0220eafde4b1
- Distribution End Date
- 2020-04-30
Device Description
Bundle of two thermometers: OCCOscan - The Non-contact Infrared Thermometer uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. OCCOflex - Digital Thermometer enables fast and reliable measurements. These thermometers provide very high clinical accuracy and have been designed to provide maximum user-friendliness. Digital Thermometer series can be used in conjunction with or without a disposable probe cover when preferred. The basic principle of these thermometers is that a change of thermistor resistance, caused by changes in temperature, is converted to changes of frequency of R-C oscillator circuit. Therefore, the temperature can be given by measuring the frequency of the oscillator. For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.
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
- No
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14035 | Intermittent electronic patient thermometer | A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device. | 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 |
|---|---|---|---|---|---|---|
| Primary | 00863101000320 | GS1 | ||||
| Package | 10863101000327 | GS1 | carton | 50 | Not in Commercial Distribution | 2020-04-30 |