ProGen PC Kit BELL-82380-A

GUDID 00861122000312

The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.

CELLMEDIX HOLDINGS, LLC

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• Primary Device ID: 00861122000312
• NIH Device Record Key: 7f0c59c8-cd07-4cea-afd5-d19df00403d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGen PC Kit
• Version Model Number: BELL-82380-A
• Catalog Number: BELL-82380-A
• Company DUNS: 080357711
• Company Name: CELLMEDIX HOLDINGS, LLC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861122000312 [Primary]
GS1	10861122000319 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK130079

FDA Product Code

• ORG: Platelet And Plasma Separator For Bone Graft Handling

Sterilization

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

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

[00861122000312]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-12-21

Devices Manufactured by CELLMEDIX HOLDINGS, LLC

• 10861122000302 - Centripid PC: 2019-04-09 The Centrepid PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrate
• 00861122000312 - ProGen PC Kit: 2019-04-09The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates high platelet yield in a highly reproducible manner. This is accomplished by inclusion of design elements that provide appropriate directional, and selectable, cell layer aspiration within the horizontally dispersed “buffy coat” in the centrifuge tube design. The design resembles the shape, and general construction, of a standard 50ml centrifuge tube, but differs from such standard products by inclusion of proprietary structural components. The similarities in design allow such devices to be centrifuged in any tabletop centrifuge that accepts a 50ml tube and is, additionally, capable of 1900 RCF at 3500 RPM, 4X50ml capacity and 30-minute timer.
• 00861122000312 - ProGen PC Kit: 2019-04-09 The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates h
• 10861122000326 - Phlebotomy Kit: 2018-03-29
• 00861122000336 - ProGen Phlebotomy Kit: 2018-03-29