| Primary Device ID | 00634782553050 |
| NIH Device Record Key | 83e67fe1-cd91-40cc-829f-3a50ca921c8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adtemp™ |
| Version Model Number | 419 |
| Catalog Number | 419 |
| Company DUNS | 108999095 |
| Company Name | AMERICAN DIAGNOSTIC 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 | true |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00634782053260 [Primary] |
| GS1 | 00634782500054 [Package] Contains: 00634782853044 Package: Master Case [12 Units] In Commercial Distribution |
| GS1 | 00634782553050 [Package] Contains: 00634782853051 Package: Master Case [20 Units] Discontinued: 2019-05-14 Not in Commercial Distribution |
| GS1 | 00634782853044 [Package] Contains: 00634782053260 Package: Inner Pack [12 Units] In Commercial Distribution |
| GS1 | 00634782853051 [Package] Contains: 00634782053260 Package: Inner Pack [25 Units] Discontinued: 2019-05-14 Not in Commercial Distribution |
| FLL | Thermometer, Electronic, Clinical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-05-15 |
| Device Publish Date | 2016-09-21 |
| 00634782548292 | ADTEMP Dig Sheaths,5000/pkg |
| 00634782595333 | ADTEMP II, Dual Scale, Oral,Dig Therm, Blue, 30s, Canada |
| 00634782588335 | ADTEMP V Digital Thermometer,8 sec, Lrg Disp, Flex tip |
| 00634782085186 | Wall Cradle, Non-Contact Therm,Acrylic w/hardware & box, RM |
| 00634782584863 | ADTEMP Non-Contact Thermometer,F/C |
| 00634782584412 | ADTEMP Ultra Dig Thermometer,2 sec, Flex tip, Lrg Disp |
| 00634782584375 | ADTMEP II, Dual Scale, Rectal,Dig Thermometer, 30s, Disp pkg |
| 00634782584368 | ADTEMP II, Dual Scale, Oral,Dig Therm, Blue, 30s, Disp pkg |
| 00634782564957 | ADTEMP Tympanic F/C Canadian,Digital Thermometer w/covers |
| 00634782564315 | ADTEMP IV Flex-tip, 10 sec,Digital Thermometer, Lrg Disp |
| 00634782563479 | ADTEMP II General Practice Kit,Digital Thermometers w/Sheaths |
| 00634782563066 | ADTEMP Temple Touch,Digital Thermometer, Disp pkg |
| 00634782563059 | ADTEMP Temple Touch,Digital Thermometer |
| 00634782562755 | ADTEMP Tympanic F/C,Digital Thermometer, w/covers |
| 00634782554569 | ADTEMP VI Veterinary Therm,Dual Scale, Bulk |
| 00634782553470 | ADTEMP Tympanic, F/C,Digital Thermometer |
| 00634782553463 | ADTEMP Digital Sheaths,50/pkg |
| 00634782553456 | ADTEMP IV, SPU Dual Scale,Dig Thermometer Kit, Lrg Disp |
| 00634782553449 | ADTEMP IV, Dual Scale, 10 sec,Digital Thermometer, Lrg Disp |
| 00634782553432 | ADTEMP II, SPU Dual Scale, Red,Dig Therm Kit,Rectal, 30 sec |
| 00634782553425 | ADTEMP II, Dual Scale, Rectal,,Dig Therm, Red, 30 sec, Bulk |
| 00634782553418 | ADTEMP II, Dual Scale, Rectal,Dig Therm, Red, 30 sec |
| 00634782553401 | ADTEMP II SPU, Dual Scale,Oral,Dig Therm Kit, Blue, 30 sec |
| 00634782553395 | ADTEMP II,Dual Scale, Oral,Dig Therm, Blue, 30 sec, Bulk |
| 00634782553388 | ADTEMP II, Dual Scale, Oral,Dig Therm, Blue, 30 sec |
| 00634782553050 | ADTEMP Hypothermia,Dig Therm, 10/18 sec, Bulk |
| 00634782548391 | ADTEMP V Dig Therm, 8 sec, |
| 00634782548339 | ADTEMP I SPU Digital,Thermometer Kit |
| 00634782548322 | ADTEMP I Digital Thermometer,Bulk, no sheaths included |
| 00634782502539 | ADTEMP Digital Sheaths,1000/pkg |
| 00634782502522 | ADTEMP Digital Sheaths,100/pkg |
| 00634782597443 | ADTEMP Mini Non-Contact Therm,w/ Lanyard |
| 00634782899783 | ADTEMP Non-Contact IR Therm, |
| 00634782899806 | ADTEMP Non-Contact IR Therm, |
| 00634782903039 | Adtemp™ 424N IR Tympanic Thermometer, 1 second, w/ Cradle & Probe covers |
| 00634782603106 | Adtemp™ 424N IR Tympanic Thermometer, Probe Covers, 10/pkg, 200/ct. |
| 00634782903091 | Adtemp™ 424N IR Tympanic Thermometer, Probe Covers, 2/pkg, 40/ct. |