VitalScreen

GUDID 54119670000430

VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm vitality by dye exclusion. The kit consist of 20ml of

Fertipro NV

Nigrosin solution IVD
Primary Device ID54119670000430
NIH Device Record Key443b5b01-2a54-4719-a398-3829a36d7f30
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitalScreen
Version Model NumberVITAL
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 Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS154119670000430 [Primary]

FDA Product Code

LEDStains, Chemical Solution

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-24
Device Publish Date2018-08-22

On-Brand Devices [VitalScreen]

54119670000430VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm
05411967000043VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm

Trademark Results [VitalScreen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VITALSCREEN
VITALSCREEN
76426459 not registered Dead/Abandoned
Planar Systems, Inc.
2002-07-01
VITALSCREEN
VITALSCREEN
76115649 2637623 Dead/Cancelled
NDS SURGICAL IMAGING, LLC
2000-08-23

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