Actherm
GUDID 06972325560160
Dongguan Actherm Medical Corp.
Intermittent electronic patient thermometer| Primary Device ID | 06972325560160 |
| NIH Device Record Key | 53aa6341-b83c-4250-a615-71eb67db1d02 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Actherm |
| Version Model Number | 3030+Ex |
| Company DUNS | 544571542 |
| Company Name | Dongguan Actherm Medical Corp. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06972325560160 [Primary] |
| GS1 | 06972325560436 [Package] Package: [12 Units] In Commercial Distribution |
| GS1 | 06972325560641 [Package] Package: [240 Units] In Commercial Distribution |
| GS1 | 06972325560894 [Package] Package: [100 Units] In Commercial Distribution |
| GS1 | 06972325561143 [Package] Package: [600 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K070028
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 | 2019-06-24 |
| Device Publish Date | 2019-06-14 |
On-Brand Devices [Actherm]
| 06972325560313 | Probe Cover |
| 06972325560290 | ACT8000-D |
| 06972325560283 | ACT8000-b |
| 06972325560276 | ACT8000-S |
| 06972325560269 | ACT8000-C |
| 06972325560252 | 3230 Basal |
| 06972325560245 | 3230+Ex |
| 06972325560238 | 3230 Ex |
| 06972325560221 | 3230+ |
| 06972325560214 | 3230 |
| 06972325560207 | 3020+Ex |
| 06972325560191 | 3020 Ex |
| 06972325560184 | 3020+ |
| 06972325560177 | 3020 |
| 06972325560160 | 3030+Ex |
| 06972325560153 | 3030 Ex |
| 06972325560146 | 3030+ |
| 06972325560139 | 3030 |
| 06972325560122 | 2130+Ex |
| 06972325560115 | 2130 Ex |
| 06972325560108 | 2130+ |
| 06972325560092 | 2130 |
| 06972325560085 | 2020+Ex |
| 06972325560078 | 2020 Ex |
| 06972325560061 | 2020+ |
| 06972325560054 | 2020 |
| 06972325560047 | 2030+Ex |
| 06972325560030 | 2030 Ex |
| 06972325560016 | 2030 |
| 06972325560009 | 2030+ |
Trademark Results [Actherm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACTHERM 76547996 2874112 Live/Registered |
ACTHERM INC. 2003-09-29 |
 ACTHERM 76547995 2937341 Dead/Cancelled |
ACTHERM INC. 2003-09-29 |
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