| Primary Device ID | 04942962608619 | 
| NIH Device Record Key | f491f899-74fa-4d9f-ae1c-0e831969ca80 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Semi-Iris Access Port Cover(20 pcs/pkg) | 
| Version Model Number | 60861 | 
| Catalog Number | 60861 | 
| Company DUNS | 690632047 | 
| Company Name | ATOM MEDICAL CORPORATION | 
| Device Count | 20 | 
| DM Exempt | true | 
| 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 | 
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | |
| Phone | +81 488533661 | 
| hitoshi.hayashi@atomed.co.jp | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04942962608619 [Primary] | 
| GS1 | 84942962608615 [Unit of Use] | 
| FPL | Incubator, Neonatal Transport | 
| 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 |