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 ID00855306003053
NIH Device Record Keya4fd9aa5-8fd0-4835-934b-d09d4294542e
Commercial Distribution StatusIn Commercial Distribution
Brand NameConcentrating System PRP-S 60mL GenesisCS Component Concentrating System
Version Model Number620-11-09
Catalog Number620-11-09
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
GS100855306003053 [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

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

Devices Manufactured by EMCYTE CORP.

00855306003008 - AbsolutePRP 60mL GenesisCS Component Concentrating System2019-04-09
00855306003015 - Accelerate Platelet Concentrating System 60mL2019-04-09
00855306003022 - Accelerate Platelet Concentrating System PRP-S 30mL2019-04-09
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
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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