Concentrating System PRP-S 60mL GenesisCS Component Concentrating System 620-11-09

GUDID 00855306003053

EMCYTE CORP.

Haematological concentrate system preparation kit, bone marrow concentration

• Primary Device ID: 00855306003053
• NIH Device Record Key: a4fd9aa5-8fd0-4835-934b-d09d4294542e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Concentrating System PRP-S 60mL GenesisCS Component Concentrating System
• Version Model Number: 620-11-09
• Catalog Number: 620-11-09
• 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

Customer Support Contacts

• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com
• Phone: +1(239)482-7725
• Email: support@emcyte.com

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00855306003053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK050055

FDA Product Code

• JQC: CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

[00855306003053]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-09
• Device Publish Date: 2019-01-08

Devices Manufactured by EMCYTE CORP.

• 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
• 00855306003053 - Concentrating System PRP-S 60mL GenesisCS Component Concentrating System: 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