| Primary Device ID | 04942962602167 |
| NIH Device Record Key | 147ef218-ffef-4203-9b3d-18bf3bfcd51f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Infa Lite AC100-240V |
| Version Model Number | 60216 |
| Catalog Number | 60216 |
| Company DUNS | 690632047 |
| Company Name | ATOM MEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
| Phone | +81 488533661 |
| hitoshi.hayashi@atomed.co.jp |
| Depth | 25 Centimeter |
| Width | 5.5 Centimeter |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04942962602167 [Primary] |
| KZF | Device, Medical Examination, Ac Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-01-29 |
| Device Publish Date | 2016-09-21 |
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| 04942962601450 - Face Mask For Neonatal(20 pcs/box) | 2019-01-29 |
| 04942962601467 - Face Mask For Infant(20 pcs/box) | 2019-01-29 |
| 04942962602167 - Infa Lite AC100-240V | 2019-01-29 |
| 04942962602167 - Infa Lite AC100-240V | 2019-01-29 |
| 04942962602693 - Pneumoclean Electrostatic Filter(5 pcs/pkg) | 2019-01-29 |
| 04942962602983 - Test Bag, 50mL | 2019-01-29 |
| 04942962603058 - Oxygen Sensor For V-808 | 2019-01-29 |
| 04942962603171 - Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-8 | 2019-01-29 |