Centripid PC CELL-80180-A

GUDID 10861122000302

The Centrepid 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 ID10861122000302
NIH Device Record Key19cd8cdb-6c0d-46ef-a1e3-e3b7f4cdf0f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCentripid PC
Version Model NumberCELL-80180-A
Catalog NumberCELL-80180-A
Company DUNS080357711
Company NameCELLMEDIX HOLDINGS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com
Phone1-800-392-6310
Emailinfo@cellmedix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100861122000305 [Primary]
GS110861122000302 [Package]
Contains: 00861122000305
Package: Shipper Box [10 Units]
Discontinued: 2017-01-04
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

[10861122000302]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-09
Device Publish Date2017-01-09

Devices Manufactured by CELLMEDIX HOLDINGS, LLC

10861122000302 - Centripid PC2019-04-09The Centrepid 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.
10861122000302 - Centripid PC2019-04-09 The Centrepid PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrate
00861122000312 - ProGen PC Kit2019-04-09 The ProGen PC design concept is predicated on providing an easy to use device for platelet rich plasma (PRP) that demonstrates h
10861122000326 - Phlebotomy Kit2018-03-29
00861122000336 - ProGen Phlebotomy Kit2018-03-29
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