Accelerate Platelet Concentrating System PRP-S 30mL 620-11-06

GUDID 00855306003039

EMCYTE CORP.

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Primary Device ID00855306003039
NIH Device Record Key45b43a75-0ce8-4421-bb93-09434ad4655b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccelerate Platelet Concentrating System PRP-S 30mL
Version Model Number620-11-06
Catalog Number620-11-06
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
GS100855306003039 [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

[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


[00855306003039]

Ethylene Oxide


Device Entry Metadata

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

On-Brand Devices [Accelerate Platelet Concentrating System PRP-S 30mL]

00855306003039620-11-06
00855306003022620-11-07

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