PurePRP 60mL GenesisCS Component Concentrating System GS60-PURE

GUDID 00855306003183

EMCYTE CORP.

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Primary Device ID00855306003183
NIH Device Record Key0408b4b2-58b4-406a-88c5-66726fdac757
Commercial Distribution StatusIn Commercial Distribution
Brand NamePurePRP 60mL GenesisCS Component Concentrating System
Version Model NumberGS60-PURE
Catalog NumberGS60-PURE
Company DUNS021599728
Company NameEMCYTE CORP.
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com
Phone+1(239)482-7725
Emailsupport@emcyte.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100855306003183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JQCCENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


[00855306003183]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-09
Device Publish Date2019-01-08

Devices Manufactured by EMCYTE CORP.

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00855306003039 - Accelerate Platelet Concentrating System PRP-S 30mL2019-04-09
00855306003046 - Accelerate Platelet Concentrating System PRP-S 60mL2019-04-09
00855306003053 - Concentrating System PRP-S 60mL GenesisCS Component Concentrating System2019-04-09
00855306003084 - AbsolutePRP 120mL GenesisCS Component Concentrating System2019-04-09
00855306003091 - AbsoluteBMC 120mL GenesisCS Component Concentrating System2019-04-09

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