Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222779

FEI Number

1000120774

Entity Name

LifeGlobal Group, LLC

City/State/Country

Trumbull, CT, US

Establishment Address

95 Corporate Dr, Trumbull, CT 06611, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

LifeGlobal Group, LLC (Owner Number: 9003605)

Owner / Operator Contact Address

95 Corporate Drive, --, Trumbull, CT 06611, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080395

PMA Number

N/A

All Registered Proprietary Names

Global Fertilization GLOBAL Embryo Culture and Transfer global Collect Washing mHTF w/HEPES & Phenol Red Media Culture System HTF w/Hepes Global w/Hepes LG HSA Pioneer Pro-Pump Single LifeGlobal® Global® Total® LP w/Hepes LifeGlobal® Global® Total® LP for Fertilization LifeGlobal® Global® Total® LP Protein Supplement global DMSO Blastocyst Vitrification Warming Kit global® DMSO Blastocyst Vitrification Kit LifeGuard Oil LiteOil global® Blastocyst Fast Thawing Kit Life Global Total for Fertilization LifeGlobal Total w/HEPES LifeGlobal Total Embryo Corral Dish Embryo GPS Dish Coda Air Filtration System Genx Coda Air Purification Coda Inline Filters Coda Eco 1500, Coda Eco 1200 Coda Aero 500, Coda Aero 700 CodaAir 800, CodaAir900 Coda Positive Pressure Unit Coda Unit Dual Vacuum Pioneer Pro-Pump LifeGlobal Global HP 4Well GPS Dish MicroDrop GPS Dish Mini GPS Dish Universal GPS Dish 38 Special GPS Dish

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2008-01-24
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2008-01-24
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2009-12-18
HHK	Curette, Suction, Endometrial (And Accessories)	Obstetrics/Gynecology	Class 2	884.1175	2008-02-28
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2015-02-18
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-12-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-12-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2014-02-19
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2016-04-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2012-06-19
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2006-11-14
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2008-01-24
HHK	Curette, Suction, Endometrial (And Accessories)	Obstetrics/Gynecology	Class 2	884.1175	2014-01-09
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2015-02-18
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2016-08-18

Official Correspondent

Brian Szeremeta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LifeGlobal Group, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K011481	Conception Technologies	10% PVP; 10% PVP IN EBSS SOLUTION	2001-07-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2020	CooperSurgical, Inc.	2	Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.

Similar Registrations

Registration Number	Establishment Name	Location
2031824	Vitrolife Inc.	San Diego, CA, US
3014295858	COOPER MEDICAL, SRL	La Garita Alajuela, CR
3014755376	CooperSurgical Distribution B.V.	Herten Limburg, NL
3036725842	GYNOTEC B.V.	Malden Gelderland, NL
3004048494	ORIGIO A/S	Ballerup Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222779. Last updated year: 2026. Please use registration number 1222779 when referencing this establishment in official correspondence.