SteadyTemp
GUDID 09120095900281
SteadySense GmbH
Wireless patient thermometer, single-use| Primary Device ID | 09120095900281 |
| NIH Device Record Key | 820f6460-50a0-409c-ad67-767b3ec60c20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SteadyTemp |
| Version Model Number | 1 |
| Company DUNS | 300492871 |
| Company Name | SteadySense GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09120095900281 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K233280
FDA Product Code
| FLL | Thermometer, Electronic, Clinical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-23 |
| Device Publish Date | 2024-07-15 |
Devices Manufactured by SteadySense GmbH
| 09120095900281 - SteadyTemp | 2024-07-23 |
| 09120095900281 - SteadyTemp | 2024-07-23 |
| 09120095900274 - femSense Ovulation Tracker | 2022-11-03 |
| 09120095900021 - femSense Fertility | 2021-07-23 |
| 09120095900014 - femSense Kinderwunsch | 2021-05-25 |
Trademark Results [SteadyTemp]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STEADYTEMP 79301144 not registered Live/Pending |
SteadySense GmbH 2020-09-11 |
 STEADYTEMP 78316254 2985050 Dead/Cancelled |
Innovative Marketing & Distribution Inc. 2003-10-21 |
 STEADYTEMP 75739994 not registered Dead/Abandoned |
SEARS, ROEBUCK AND CO. 1999-06-30 |
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