| Primary Device ID | 00855306003411 |
| NIH Device Record Key | 8774eb1d-8018-4ec0-b288-d4bc5f582f97 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PureBMC-60mL GenesisCS Component Concentrating System |
| Version Model Number | BC60-PURE |
| Catalog Number | BC60-PURE |
| Company DUNS | 021599728 |
| Company Name | EMCYTE CORP. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com | |
| Phone | +1(239)482-7725 |
| support@emcyte.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 | 00855306003411 [Primary] |
| JQC | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
[00855306003411]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2019-01-08 |