Human Tubal Fluid (HTF) Medium with Gentamicin 90125

GUDID 00810195240415

HTF Medium is a synthetic, defined solution for use as a culture media through Day 3 of human embryo development as well as the processing of gametes. HTF is bicarbonate-based and is designed for use in a CO2 incubator. HTF contains the antibiotic Gentamicin Sulphate.

IRVINE SCIENTIFIC, LLC

IVF medium
Primary Device ID00810195240415
NIH Device Record Key718169d9-bd36-4f9c-bd92-d2c06800b542
Commercial Distribution StatusIn Commercial Distribution
Brand NameHuman Tubal Fluid (HTF) Medium with Gentamicin
Version Model Number90125-100ML
Catalog Number90125
Company DUNS121584789
Company NameIRVINE SCIENTIFIC, LLC
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 Usefalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810195240415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQLMedia, Reproductive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-10
Device Publish Date2025-06-02

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