| Primary Device ID | 04942962603171 | 
| NIH Device Record Key | b603f84d-6765-4c49-9254-d904461c0e02 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-8 | 
| Version Model Number | 60317 | 
| Catalog Number | 60317 | 
| Company DUNS | 690632047 | 
| Company Name | ATOM MEDICAL CORPORATION | 
| Device Count | 10 | 
| 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 | 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 | |
| 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 | 04942962603171 [Primary] | 
| GS1 | 84942962603177 [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 |