Universal IVF Medium

GUDID 20888937800306

Universal IVF Medium with phenol red. 60 ml

Origio A/S

IVF medium
Primary Device ID20888937800306
NIH Device Record Key2950e8e4-410a-47ed-a86a-4d049aeb70e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal IVF Medium
Version Model Number10310060D
Company DUNS305424269
Company NameOrigio A/S
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937800302 [Primary]
GS120888937800306 [Package]
Contains: 00888937800302
Package: 10315060D 5x60 ml [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQLMedia, Reproductive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-15

On-Brand Devices [Universal IVF Medium]

20888937817199Universal IVF Medium with phenol red. 10x10 ml
20888937817151Universal IVF Medium. 10x10 ml
20888937800306Universal IVF Medium with phenol red. 60 ml
20888937800214Universal IVF Medium. 60 ml

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