Modified Ham's F-10 with Albumin 99109

GUDID 00893727002934

Modified Ham's F-10 w/Albumin

FUJIFILM IRVINE SCIENTIFIC, INC.

IVF medium
Primary Device ID00893727002934
NIH Device Record Key4f85a83b-d206-4788-8746-1824db22c4f9
Commercial Distribution Discontinuation2023-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameModified Ham's F-10 with Albumin
Version Model Number99109-12X12ML
Catalog Number99109
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 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
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

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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100893727002934 [Primary]
GS110893727002931 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HDRCap, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2024-02-12
Device Publish Date2016-09-10