CryoStore CS500KS

GUDID 20816203023739

CryoStore 500 EVA Freezing Bag, 55 - 100ml "K" Tube Set, double aseptically packed.

ORIGEN BIOMEDICAL, INC.

Blood/tissue storage/culture container
Primary Device ID20816203023739
NIH Device Record Key1e95bbb3-4a51-495f-8d5f-499e85ef11bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameCryoStore
Version Model NumberCS500KS
Catalog NumberCS500KS
Company DUNS625272232
Company NameORIGEN BIOMEDICAL, INC.
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone512-474-7278
Emailregulatory@origen.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com
Phone+1-512-474-7278
Emailregulatory@origenbio.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not re-use
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Special Storage Condition, SpecifyBetween 0 and 0 *Do not resterilize

Device Identifiers

Device Issuing AgencyDevice ID
GS110816203023732 [Primary]
GS120816203023739 [Package]
Contains: 10816203023732
Package: Case [12 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-23
Device Publish Date2023-03-15

On-Brand Devices [CryoStore]

20816203023647CryoStore 250 EVA Freezing Bag, 30-70ml, "K" Tube Set, double aseptically packed
20816203023586CryoStore multiple bag set, six 20 EVA freezing bags, 20-30ml, "V6" Tube Set
20816203023579CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "NS" Tube Set
20816203023562CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "F" Tube Set
20816203023555CryoStore 20 EVA 5-Chamber Freezing Bag, 20-30ml, "N" Tube Set
20816203023425Cryostore 500 EVA Freezing Bag, 55-100ml, "N" Tube Set, singly packed
20816203023302CryoStore 50 EVA Freezing Bag, 7-Bag Set, 10-30ml, "V9" Tube Set
10816203023169Cryostore 50 EVA Freezing Bag, 4-bag Set, 10-30ml, "V8" tubing set
20816203023159CryoStore 500 EVA Freezing Bag, 8-bag set, 55-100ml, "V8" Tube Set
10816203022865Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "N" Tubing Set, case of 24
10816203022841Cryostore 28 EVA Freezing Bag, 5-20 ml, F tube set, case of 24
20816203022244Cryostore 250 EVA Freezing Bag, 30 - 70 ml, "F1" Tubing Set, case of 24
10816203022230Cryostore 2000 EVA Freezing Bag, 180-450ml, "Standard" Tube Set, case of 24
10816203021547Cryostore 2500 Conical EVA Freezing Bag, 730-810ml, " Y14" Tubing Set, case of 12
20816203021537Cryostore 750 EVA Freezing Bag, 80 - 190 ml, Standard Tubing Set, case of 24
20816203021520Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y11" Tubing Set, case of 50
20816203021513Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y10" Tubing Set, case of 24
10816203021509Cryostore 750 EVA 3-Bag set with drip spikes, 80-190ml, case of 6 sets
10816203021493Cryostore 750 EVA Freezing Bag, 80-190ml, 3- Bag set with "V3" Tube Set, 1 set per pouch, case
10816203021455Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "M2" tube set, case of 12, double pouched
20816203021445Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F8" tube set, case of 24
20816203021438Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F5" tube set, case of 20
20816203021421Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F5" tube set, case of 24
10816203021417Cryostore 750 EVA Freezing Bag, 80 - 190 ml, F1 tube set, double aseptic packed, case of 12
20816203021407Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "Y3" Tubing Set, case of 24
10816203021387Cryostore 50 EVA 4- Bag Set, 10-30ml, "Standard" Tubing Set, 1 set per pouch, case of 6
10816203021370Custom 50 EVA 2-Bag set with spikes, 10-30ml, 1 set per pouch, case of 12
10816203021363Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, singly packed in OW
10816203021356Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, triply packed
10816203021349Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, singly packed
20816203021339Cryostore 50 EVA Freezing Bag, 10 - 30 ml, M3 tube set, case of 24
20816203021322Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 24, heat sealed
10816203021318Cryostore 50 EVA Freezing Bag, 10-30ml, "F4" Tubing Set, double aseptically pouched, case of 12
20816203021278Cryostore 50 EVA Freezing Bag, 10-30ml, "F15" Tubing Set, case of 24
10816203021264Cryostore 500 EVA 3-Bag set with spikes, 55-100ml, 1 set per pouch, case of 8 sets
10816203021257Custom 500ml EVA 2-bag set with spikes, 1 set per pouch, 12 sets per case
20816203021247Custom 500ml EVA 2-bag set with spikes, 2 sets per Tyvek pouch, 12 sets per case
10816203021233Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed in OW
10816203021226Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed
20816203021216Cryostore 500 EVA Freezing Bag, 55 - 100 ml "M4" Tubing Set, case of 24
20816203021209Cryostore 500 EVA Freezing Bag, custom length, Standard Tubing Set, case of 24
10816203021196Cryostore 500 EVA Bag, custom-width, N-tube set, in custom-width O-Wrap, case of 12
10816203021189Cryostore 500 EVA Freezing Bag, custom width, "N" Tubing Set, case of 12
20816203021179Cryostore 500 EVA Freezing Bag, custom width, "N" Tubing Set, case of 24
10816203021165Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "F1" Tubing Set, double aseptic packed, case of 12
20816203021155Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "F16" Tubing Set, case of 24
20816203021148Cryostore 500 EVA Freezing Bag, 55 - 100 ml Standard Tubing Set, case of 24
20816203021131Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, 4 per triply pouched,
20816203021124Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 24
20816203021117Cryostore 400ml EVA Freezing Bag with standard tube set, 24 per case

Trademark Results [CryoStore]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CRYOSTORE
CRYOSTORE
78252947 not registered Dead/Abandoned
OriGen Biomedical
2003-05-22

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