FertiCult High Viscosity Oil

GUDID 05411967001255

FertiCult High Viscosity Oil - HVOIL500P (500ml in PETG bottle) is pre-washed with water, ready to use, high viscosity mineral oil (d=0.86-0.88g/ml) for use in In Vitro Fertilization (IVF), Intracytoplasmatic Sperm Injection (ICSI) and Assisted reproductive technologies (ART). For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com).

Fertipro NV

IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium
Primary Device ID05411967001255
NIH Device Record Keyac355934-7a2e-4220-8fa3-e6c72c537d26
Commercial Distribution StatusIn Commercial Distribution
Brand NameFertiCult High Viscosity Oil
Version Model NumberHVOIL500P
Company DUNS373904101
Company NameFertipro NV
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com
Phone+3250791805
Emailinfo@fertipro.com

Device Dimensions

Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter
Total Volume500 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from (sun)light and avoid exposure to sources of irradiation

Device Identifiers

Device Issuing AgencyDevice ID
GS105411967000500 [Primary]
GS105411967001255 [Package]
Contains: 05411967000500
Package: [1 Units]
In Commercial Distribution

FDA Product Code

QKIMedia, Reproductive, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-08
Device Publish Date2023-02-28

On-Brand Devices [FertiCult High Viscosity Oil]

05411967001224FertiCult High Viscosity Oil - HVOIL500 (500ml in glass bottle) is pre-washed with water, ready
05411967001200FertiCult High Viscosity Oil - HVOIL100 (100ml in glass bottle) is pre-washed with water, ready
05411967001187FertiCult High Viscosity Oil - HVOIL050 (50ml in glass bottle) is pre-washed with water, ready t
05411967001255FertiCult High Viscosity Oil - HVOIL500P (500ml in PETG bottle) is pre-washed with water, ready
05411967001248FertiCult High Viscosity Oil - HVOIL100P (100ml in PETG bottle) is pre-washed with water, ready
05411967001231FertiCult High Viscosity Oil - HVOIL050P (50ml in PETG bottle) is pre-washed with water, ready t
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