Data / Medical devices / United States / LifeGlobal Group, LLC
LifeGlobal Group, LLC: FDA-registered device maker in Trumbull, CT, United States, 17 510(k) clearances
LifeGlobal Group, LLC is registered with the FDA (registration 1222779) in Trumbull, CT, United States. It lists 4 device types. The FDA files 17 510(k) clearances under its listings, the newest dated February 17, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1222779
- FEI number
- 1000120774
- Address
- 95 Corporate Dr, Trumbull, CT, United States, 06611
- Owner or operator
- LifeGlobal Group, LLC (9003605)
- Roles
- Specification developer
- First device listed
- November 14, 2006
- Registered through
- 2026
- Brand names listed
- 38 Special GPS Dish, 4Well GPS Dish, Coda Aero 500, Coda Aero 700, Coda Air Filtration System, Coda Eco 1500, Coda Eco 1200, Coda Inline Filters, Coda Positive Pressure Unit, Coda Unit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Assisted Reproduction | MQG | 2 | Specification developer | accessdata.fda.gov |
| Curette, Suction, Endometrial (And Accessories) | HHK | 2 | Specification developer | accessdata.fda.gov |
| Labware, Assisted Reproduction | MQK | 2 | Specification developer | accessdata.fda.gov |
| Media, Reproductive | MQL | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 17, 2015 | K142991 | LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA | MQL | Substantially Equivalent | Life Global Group, LLC | accessdata.fda.gov |
| January 20, 2015 | K143498 | LifeGlobal Global HP | MQL | Substantially Equivalent | Life Global Group, LLC | accessdata.fda.gov |
| May 3, 2012 | K112083 | LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| January 14, 2011 | K092963 | GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 | MQL | Substantially Equivalent | Genx Intl., Inc. | accessdata.fda.gov |
| June 3, 2010 | K092667 | GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT | MQL | Substantially Equivalent | Genx Intl., Inc. | accessdata.fda.gov |
| April 5, 2010 | K092578 | LIFEGLOBAL PROTEIN SUPPLEMENT | MQL | Substantially Equivalent | Genx Intl., Inc. | accessdata.fda.gov |
| April 24, 2009 | K083509 | LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA | MQL | Substantially Equivalent | Genx Intl., Inc. | accessdata.fda.gov |
| August 13, 2008 | K080395 | SUNIVF DISHES | MQK | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| May 19, 2006 | K053552 | GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| May 9, 2006 | K053551 | MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| June 25, 2004 | K040530 | MEDIA CULTURE SYSTEM | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| August 23, 2002 | K022332 | LITE MINERAL OIL | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| September 15, 2000 | K001486 | GENX CODA AIR PURIFICATION SYSTEM | MQG | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| February 14, 2000 | K993881 | GENX CULTURE DISH | MQK | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| July 19, 1999 | K991173 | <GENX> FERTILIZATION MEDIA-HTF | MQL | Substantially Equivalent | <Genx> Intl., Inc. | accessdata.fda.gov |
| March 4, 1992 | K914241 | PIONEER PRO-PUMP DUAL CONTROL | HHK | Substantially Equivalent | Pioneer Medical, Inc. | accessdata.fda.gov |
| March 4, 1992 | K914220 | PIONEER PRO-PUMP | HHK | Substantially Equivalent | Pioneer Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Reproductive
- All makers of Curette, Suction, Endometrial (And Accessories)
- All makers of Accessory, Assisted Reproduction
- All makers of Labware, Assisted Reproduction
Updated February 17, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.