| Primary Device ID | 05391525570006 |
| NIH Device Record Key | c9b4f1fd-4a5b-4fc7-9ee4-a90c662bcc19 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARC InstaTemp Non-Touch Thermometer |
| Version Model Number | 000 |
| Company DUNS | 079758824 |
| Company Name | ARC DEVICES USA INC |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05391525570006 [Primary] |
| FLL | Thermometer, Electronic, Clinical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-03-27 |
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| 05391525574014 - ARC InstaTemp Non-Touch Infrared Thermometer | 2018-03-29 The ARC InstaTemp MD Digital Non-Touch Infrared Thermometer is intended to be used in the clinical setting to measure temperatur |
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| 00853524006011 - ARC InstaTemp Infrared Thermometer | 2018-03-29 InstaTemp Digital Non-Touch Thermometer is intended to be used to measure temperature in infants and adults. The InstaTemp can |
| 00853524006023 - ARC InstaTemp Infrared Thermometer | 2018-03-29 InstaTemp Digital Non-Touch Infrared Thermometer intended to be used to measure temperature in infants and adults This device c |