CryoMACS® Freezing Bag 50 200-074-400

GUDID 04049934000270

The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C

Miltenyi Biotec GmbH

Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container Blood/tissue storage/culture container
Primary Device ID04049934000270
NIH Device Record Keyad316388-f80d-4de6-86a2-0b964e5b4a80
Commercial Distribution StatusIn Commercial Distribution
Brand NameCryoMACS® Freezing Bag 50
Version Model Number74400
Catalog Number200-074-400
Company DUNS327036034
Company NameMiltenyi Biotec GmbH
Device Count24
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-810-3135
EmailRegulatory_affairs_USA@milteny
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com
Phone800-810-3135
EmailRegulatory_affairs_USA@miltenyibiotec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104049934000270 [Primary]
GS104049934001383 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-12-18

Devices Manufactured by Miltenyi Biotec GmbH

04049934004674 - CliniMACS PBS/EDTA Buffer 1L2019-05-31 CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of the CliniMACS CD34 Reagent System
04049934000270 - CryoMACS® Freezing Bag 502018-07-06The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing, storage (down to -196°C
04049934000270 - CryoMACS® Freezing Bag 502018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing,
04049934000287 - CryoMACS® Freezing Bag 2502018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing,
04049934000294 - CryoMACS® Freezing Bag 5002018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing,
04049934000300 - CryoMACS® Freezing Bag 7502018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing,
04049934000317 - CryoMACS® Freezing Bag 10002018-07-06 The CryoMACS® Freezing Bags are single use only, sterile (by irradiation), containers intended for a single cycle of freezing,
04049934004636 - CliniMACS Plus Instrument2018-07-06 The CliniMACS® plus Instrument is a software-controlled instrument that processes the HPC, Apheresis as part of the CliniMACS C
04049934004672 - CliniMACS PBS/EDTA Buffer 1L2018-07-06 CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of the CliniMACS CD34 Reagent System

Trademark Results [CryoMACS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CRYOMACS
CRYOMACS
79060203 3705509 Live/Registered
Miltenyi Biotec B.V. & Co. KG
2008-07-30

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