Cervos Platelet Separator Double Pack with Blood Draw CER-PRP-40-BD

GUDID 10858690006799

CER-PRP-40-BD F/G, STERILE PN: 76132-01M

RANFAC CORP.

Haematological concentrate system preparation kit, platelet concentration
Primary Device ID10858690006799
NIH Device Record Key1fb3cb71-4dce-4980-a4dd-5a6ec54cb1dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCervos Platelet Separator Double Pack with Blood Draw
Version Model NumberCER-PRP-40-BD
Catalog NumberCER-PRP-40-BD
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

Device Dimensions

Total Volume80 Milliliter
Total Volume80 Milliliter
Total Volume80 Milliliter
Total Volume80 Milliliter
Total Volume80 Milliliter
Total Volume80 Milliliter
Total Volume80 Milliliter
Total Volume80 Milliliter
Total Volume80 Milliliter
Total Volume80 Milliliter
Total Volume80 Milliliter
Total Volume80 Milliliter
Total Volume80 Milliliter

Operating and Storage Conditions

Handling 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.
Handling 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.
Handling 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.
Handling 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.
Handling 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.
Handling 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.
Handling 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.
Handling 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.
Handling 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.
Handling 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.
Handling 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.
Handling 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.
Handling 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
GS100858690006792 [Primary]
GS110858690006799 [Package]
Contains: 00858690006792
Package: INNER PACK [1 Units]
In Commercial Distribution
GS120858690006796 [Package]
Package: CASE [12 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 Date2022-08-19
Device Publish Date2022-08-11

Devices Manufactured by RANFAC CORP.

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10857878007313 - MAXX-CELL-32024-09-17 MAXX-CELL Bone Marrow Aspirate Kit w/ Biopsy Needle 11GA X 11CM MAX-CELL Needle 8GA X 15CM RJN-815 PN 74408-01M
10850023741964 - BANRAN-112024-07-18 BANRAN-11, F/G, STERILE, P/N 76153-01M
10850023741896 - CER-PRP-JUVA 2024-05-23 CER-PRP-JUVA F/G, STERILE PN: 76145-01M
00850023741929 - CER-JUVA-BD ASSEMBLY2024-05-23 CER-JUVA-BD Assembly PN 69014-01M
00850023741936 - CER-PRP-JUVA-KIT2024-05-23 CER-PRP-JUVA-KIT F/G, STERILE PN: 76152-01M
10850023741957 - MC-RAN-BZL-8C2024-05-14 MC-RAN-BZL-8C F/G, STERILE, P/N 74431-01M
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