FREEZE-KIT 1

GUDID 07350025910055

Vitrolife Sweden AB

IVF medium kit
Primary Device ID07350025910055
NIH Device Record Key29c57453-9122-4fbd-ae56-3af0c8f20403
Commercial Distribution StatusIn Commercial Distribution
Brand NameFREEZE-KIT 1
Version Model Number10066
Company DUNS631805488
Company NameVitrolife Sweden AB
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 Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107350025910055 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-24
Device Publish Date2016-09-13

Devices Manufactured by Vitrolife Sweden AB

07350025910901 - EmbryoGlue2022-02-07
07350025910765 - HYASE-10X2022-01-10
07350025910833 - HYASE-10X2021-07-01
07350025910796 - G-RINSE2021-06-04
07350025910802 - ASP2021-06-04
07350025910819 - G-MOPS2021-06-04
07350025910826 - G-MOPS PLUS2021-06-04
07350025910604 - Gx-IVF2021-05-31

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