MC Vitrification Warming

GUDID 60888937801783

MC Vitrification Warming. 5x2 ml

Origio A/S

IVF medium kit IVF medium kit
Primary Device ID60888937801783
NIH Device Record Key3f04cac8-2792-43d8-af46-aa9a7bdcd237
Commercial Distribution StatusIn Commercial Distribution
Brand NameMC Vitrification Warming
Version Model Number12295002D
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 Kittrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from light
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS160888937801783 [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 Number3
Public Version Date2018-07-06
Device Publish Date2017-03-28

Devices Manufactured by Origio A/S

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00888937801491 - EmbryoAssist2019-08-29 EmbryoAssist. 10 ml
00888937833058 - SAGE 1-Step2019-03-11 Sage 1-Step GM-CSF with HSA. 3 ml
00888937833072 - SAGE 1-Step2019-03-11 SAGE 1-Step GM-CSF with SPS. 3 ml.
20888937972348 - Transem Spherical 2019-01-23 Embryo transfer catheter, spherical tip.
20888937972355 - EchoGen Spherical 2019-01-23 Embryo transfer catheter, echogenic/spherical. 24 cm

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