E+R
- Primary DI
- 06971567043066
- Company
- Wenzhou Yosun Medical Technology Co., Ltd.
- Model
- EVR0901
- Device description
- Digital Thermometer
- Published
- 2025-12-29
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Regulatory Flags
- DUNS number
- 549776846
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06971567043066 | Primary | GS1 | 0 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|---|---|---|---|---|---|---|
| 06971567043066 | Primary | GS1 | 0 |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|---|---|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 2 | General Hospital | 880.2910 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
Device Sizes
No records found.
Storage And Handling
No records found.
Sterilization Methods
| Method |
|---|
Contacts
No records found.
Other Devices From This Company
No records found.