| Primary Device ID | 00857515006078 |
| NIH Device Record Key | 8d5cc564-2252-49ed-a59d-ac41700f80f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Water for Assisted Reproductive Technologies (A.R.T.) Use |
| Version Model Number | 9307-50ML |
| Catalog Number | 9307 |
| Company DUNS | 057475246 |
| Company Name | FUJIFILM IRVINE SCIENTIFIC, INC. |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8004375706 |
| tmrequest@irvinesci.com |
| Total Volume | 50 Milliliter |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857515006078 [Primary] |
| MTW | System,Water,Reproduction,Assisted,And Purification |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-13 |
| Device Publish Date | 2016-09-10 |
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