Complete HTF Medium with SSS™ 9922

GUDID 00893727002057

Complete HTF Medium With SSS

FUJIFILM IRVINE SCIENTIFIC, INC.

IVF medium
Primary Device ID00893727002057
NIH Device Record Key4fe178d0-d67b-4614-b976-b5d3b2c9984c
Commercial Distribution Discontinuation2021-10-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameComplete HTF Medium with SSS™
Version Model Number9922-2X20mL
Catalog Number9922
Company DUNS057475246
Company NameFUJIFILM IRVINE SCIENTIFIC, INC.
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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

Device Dimensions

Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100893727002057 [Primary]
GS118937270020577 [Unit of Use]

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 Date2021-10-18
Device Publish Date2016-09-10

Devices Manufactured by FUJIFILM IRVINE SCIENTIFIC, INC.

00893727002200 - Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin2025-04-14 Freezing Medium With Gentamicin
00893727002361 - ISolate®2025-04-14 ISolate
00893727002903 - Human Serum Albumin Solution2025-04-14 Human Albumin
00893727002620 - Multipurpose Handling Medium® (MHM®)2025-03-31 Multipurpose Handling Medium® with Gentamicin
00893727002637 - Multipurpose Handling Medium® (MHM®)2025-03-31 Multipurpose Handling Medium® with Gentamicin
00893727002644 - Continuous Single Culture®2025-03-31 Continuous Single Culture® with Gentamicin
00893727002651 - Continuous Single Culture® Complete with Gentamicin Sulfate with Human Serum Alb2025-03-31 Continuous Single Culture® Complete with HSA
00893727002712 - Multipurpose Handling Medium®-Complete (MHM®-C)2025-03-31 Multipurpose Handling Medium®-Complete (MHM®-C) with Gentamicin

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.