| Primary Device ID | 00855306003046 |
| NIH Device Record Key | 58ccbffc-c97f-4839-9cca-e3daad43c7f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Accelerate Platelet Concentrating System PRP-S 60mL |
| Version Model Number | 620-11-08 |
| Catalog Number | 620-11-08 |
| 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 | 00855306003046 [Primary] |
| JQC | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00855306003046]
Ethylene Oxide
[00855306003046]
Ethylene Oxide
[00855306003046]
Ethylene Oxide
[00855306003046]
Ethylene Oxide
[00855306003046]
Ethylene Oxide
[00855306003046]
Ethylene Oxide
[00855306003046]
Ethylene Oxide
[00855306003046]
Ethylene Oxide
[00855306003046]
Ethylene Oxide
[00855306003046]
Ethylene Oxide
[00855306003046]
Ethylene Oxide
[00855306003046]
Ethylene Oxide
[00855306003046]
Ethylene Oxide
[00855306003046]
Ethylene Oxide
[00855306003046]
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 |
| 00855306003008 - AbsolutePRP 60mL GenesisCS Component Concentrating System | 2019-04-09 |
| 00855306003015 - Accelerate Platelet Concentrating System 60mL | 2019-04-09 |
| 00855306003022 - Accelerate Platelet Concentrating System PRP-S 30mL | 2019-04-09 |
| 00855306003039 - Accelerate Platelet Concentrating System PRP-S 30mL | 2019-04-09 |
| 00855306003046 - Accelerate Platelet Concentrating System PRP-S 60mL | 2019-04-09 |
| 00855306003046 - Accelerate Platelet Concentrating System PRP-S 60mL | 2019-04-09 |
| 00855306003053 - Concentrating System PRP-S 60mL GenesisCS Component Concentrating System | 2019-04-09 |
| 00855306003084 - AbsolutePRP 120mL GenesisCS Component Concentrating System | 2019-04-09 |
| 00855306003091 - AbsoluteBMC 120mL GenesisCS Component Concentrating System | 2019-04-09 |