PureBMC-120mL GenesisCS Component Concentrating System BC120-PURE

GUDID 00855306003428

EMCYTE CORP.

Haematological concentrate system preparation kit, bone marrow concentration
Primary Device ID00855306003428
NIH Device Record Key030ec32d-0154-4b66-9058-9dbe58c71592
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureBMC-120mL GenesisCS Component Concentrating System
Version Model NumberBC120-PURE
Catalog NumberBC120-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
GS100855306003428 [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

[00855306003428]

Ethylene Oxide


[00855306003428]

Ethylene Oxide


[00855306003428]

Ethylene Oxide


[00855306003428]

Ethylene Oxide


[00855306003428]

Ethylene Oxide


[00855306003428]

Ethylene Oxide


[00855306003428]

Ethylene Oxide


[00855306003428]

Ethylene Oxide


[00855306003428]

Ethylene Oxide


[00855306003428]

Ethylene Oxide


[00855306003428]

Ethylene Oxide


[00855306003428]

Ethylene Oxide


[00855306003428]

Ethylene Oxide


[00855306003428]

Ethylene Oxide


[00855306003428]

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
00855306003084 - AbsolutePRP 120mL GenesisCS Component Concentrating System2019-04-09
00855306003091 - AbsoluteBMC 120mL GenesisCS Component Concentrating System2019-04-09

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