Cervos Platelet Separator Single Pack CER-PRP-40-1

GUDID 10850023741544

CER-PRP-40-1 Platelet Single Pack PN: 76118-01M

RANFAC CORP.

Haematological concentrate system preparation kit, platelet concentration
Primary Device ID10850023741544
NIH Device Record Key4eec4f67-7353-4dcf-bdc5-2b9235a827e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCervos Platelet Separator Single Pack
Version Model NumberCER-PRP-40-1
Catalog NumberCER-PRP-40-1
Company DUNS121622872
Company NameRANFAC CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com

Device Dimensions

Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter
Total Volume40 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid excessive heat. Protect from freezing. Protect from direct sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850023741547 [Primary]
GS110850023741544 [Package]
Contains: 00850023741547
Package: Case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-18
Device Publish Date2021-11-10

On-Brand Devices [Cervos Platelet Separator Single Pack]

10850023741544CER-PRP-40-1 Platelet Single Pack PN: 76118-01M
00850023741660CER-PRP SINGLE STERILITY PACK PN: 69007-01M

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