| Primary Device ID | 04942962601467 |
| NIH Device Record Key | f15ec7d5-2178-4d06-810b-4f17ce7b0ee6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Face Mask For Infant(20 pcs/box) |
| Version Model Number | 60146 |
| Catalog Number | 60146 |
| 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 | true |
| 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 |
| Phone | +81 488533661 |
| hitoshi.hayashi@atomed.co.jp |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04942962601467 [Primary] |
| GS1 | 14942962601464 [Package] Package: BOX [20 Units] In Commercial Distribution |
| BYG | Mask, Oxygen |
| 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 |
| 04942962610858 - V-2200 Infant Incubator | 2024-11-06 |
| 04942962616102 - Neo-Servo i Atom Infant Incubator Model 102 | 2024-11-06 |
| 04942962674065 - V-2100G Advanced Infant Incubator | 2024-11-06 |
| 04942962261227 - Mattress Sheet for Neo Cot(5 pcs/pkg) | 2019-01-29 |
| 04942962601450 - Face Mask For Neonatal(20 pcs/box) | 2019-01-29 |
| 04942962601467 - Face Mask For Infant(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 |
| 04942962602693 - Pneumoclean Electrostatic Filter(5 pcs/pkg) | 2019-01-29 |