Modified Sperm Washing Medium 9984

GUDID 00893727002095

Modified Sperm Washing Medium

FUJIFILM IRVINE SCIENTIFIC, INC.

IVF medium
Primary Device ID00893727002095
NIH Device Record Key4cdaa72d-541e-44c5-b9b3-d99c9855fda0
Commercial Distribution Discontinuation2021-04-16
Commercial Distribution StatusIn Commercial Distribution
Brand NameModified Sperm Washing Medium
Version Model Number9984-12X12mL
Catalog Number9984
Company DUNS057475246
Company NameFUJIFILM IRVINE SCIENTIFIC, INC.
Device Count12
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
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

Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com

Device Dimensions

Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter
Total Volume12 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze or expose to temperatures greater than 39°C.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100893727002095 [Primary]
GS118937270020959 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQLMedia, Reproductive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-03-31
Device Publish Date2016-09-10

On-Brand Devices [Modified Sperm Washing Medium]

00893727002897Modified Sperm Washing Medium
00893727002095Modified Sperm Washing Medium

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