| Primary Device ID | 15099590625870 |
| NIH Device Record Key | 92689664-9999-4d98-a882-919f7c97c040 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COULTER Ac•T 5diff Hgb Lyse |
| Version Model Number | 8547168 |
| Catalog Number | 8547168 |
| Company DUNS | 008254708 |
| Company Name | Beckman Coulter, Inc. |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15099590625870 [Primary] |
| GGK | Products, Red-Cell Lysing Products |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-08 |
| Device Publish Date | 2020-08-31 |
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