LifeGlobal® Media
global DMSO Blast. Vitrification Warming kit..5 ml vials..
4manufacturers in China registered for this device type
93catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Shandong Wego Ruisheng Medical Device Co., Ltd. | Weihai | Shandong | Manufacturer | 2 |
Record
| Listed by | LifeGlobal Group, LLC, United States |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K092578 |
| Record published | 2016-09-21 |
| Record revised | 2026-05-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight.; Storage environment temperature 2 to 8 °C |
| Packaging | Box, lpvp-502 of 5, box, lgps-605 of 6, box, ghsa-125 of 12 |
| Distribution end date | 2024-09-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LGPS-250 | In distribution | |
| LGGH-050 | In distribution | |
| H5GT-060 | In distribution | |
| LGGG-050 | In distribution | |
| LGPO-500 | In distribution | |
| AMPO-100 | In distribution | |
| AMLO-100 | In distribution | |
| AMLG-100 | In distribution | |
| GMHH-500 | In distribution | |
| H5TF-050 | In distribution | |
| LGGF-100 | In distribution | |
| GLHP-030 | In distribution | |
| LGTF-100 | In distribution | |
| LGOL-500 | In distribution | |
| H5TH-100 | In distribution | |
| LGOL-100 | In distribution | |
| LGPS-005 | In distribution | |
| LGPS-020 | In distribution | |
| H5GT-010 | In distribution | |
| GMHT-500 | In distribution | |
| GMHT-100 | In distribution | |
| LGGG-100 | In distribution | |
| LGFR-100 | In distribution | |
| LGTF-050 | In distribution | |
| LGGT-060 | In distribution | |
| LGTF-020 | In distribution | |
| LGUA-500 | In distribution | |
| LGFR-500 | In distribution | |
| LGPO-100 | In distribution | |
| H5TF-010 | In distribution | |
| H5TH-050 | In distribution | |
| LGTH-100 | In distribution | |
| LGTH-250 | In distribution | |
| LGUA-100 | In distribution | |
| LGTH-050 | In distribution | |
| DMW5-005 | In distribution | |
| LGPS-050 | In distribution | |
| GCOL-100 | In distribution | |
| GCOL-500 | In distribution | |
| DMV5-005 | In distribution | |
| H5TF-100 | In distribution | |
| LGGH-100 | In distribution | |
| GLHP-060 | In distribution | |
| LGGF-050 | In distribution | |
| GFT5-055 | In distribution | |
| LGGH-500 | In distribution | |
| H5GT-030 | In distribution | |
| LGGG-020 | In distribution | |
| GHSA-005 | In distribution | |
| GMHH-100 | In distribution | |
| LGGT-030 | In distribution | |
| LGGT-100 | In distribution | |
| LPVP-002 | Withdrawn | |
| HGTH-250 | Withdrawn | |
| HGTF-020 | Withdrawn | |
| LGGG-250 | Withdrawn | |
| H5GT-100 | Withdrawn | |
| H5TF-020 | Withdrawn | |
| AGSS-500 | Withdrawn | |
| HGGT-060 | Withdrawn | |
| AGSS-100 | Withdrawn | |
| HGTF-100 | Withdrawn | |
| AG90-100 | Withdrawn | |
| GMHT-250 | Withdrawn | |
| LGGF-500 | Withdrawn | |
| AG45-050 | Withdrawn | |
| LGGF-020 | Withdrawn | |
| HGTH-050 | Withdrawn | |
| HGGT-100 | Withdrawn | |
| H5TH-250 | Withdrawn | |
| H5TH-020 | Withdrawn | |
| HGGT-030 | Withdrawn | |
| AGSS-250 | Withdrawn | |
| LPGG-050 | Withdrawn | |
| HGTH-100 | Withdrawn | |
| LGSF-020 | Withdrawn | |
| AG90-050 | Withdrawn | |
| AG45-100 | Withdrawn | |
| FGWG-500 | Withdrawn | |
| LGGH-250 | Withdrawn | |
| LPVP-001 | Withdrawn | |
| LPGG-020 | Withdrawn | |
| LGOL-250 | Withdrawn | |
| GALW-100 | Withdrawn | |
| GFV5-005 | Withdrawn | |
| LGSF-005 | Withdrawn | |
| LGHY-010 | Withdrawn | |
| HGTF-050 | Withdrawn | |
| LGUA-250 | Withdrawn | |
| LGPS-100 | Withdrawn | |
| GALW-500 | Withdrawn | |
| GMHH-250 | Withdrawn | |
| FGWG-100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sydney IVF | William A. Cook Australia PTY, Ltd. | 29 |
| LifeGlobal® Media | Coopersurgical, Inc. | 27 |
| VitaVitro | Shenzhen VitaVitro Biotech Co., Ltd. | 22 |
| Nidacon | Nidacon International AB | 19 |
| Sil-Select Plus Lower Layer | Fertipro NV | 8 |
| FertiCult Mineral Oil | Fertipro NV | 8 |
| Dewin | Donnevie Medical Technology (Shanghai) Co., Ltd. | 8 |
| SpermGrad | Vitrolife Sweden AB | 8 |
| Sequential Culture Media | Kitazato Corporation | 8 |
| Sperm Wash Medium | Invitrocare Inc | 7 |
| Enhance-S Plus | Vitrolife Inc. | 7 |
| G-Vitri™ Vitrification media | Gimbo Medical Technology Shenzhen Co., Ltd. | 7 |
Showing 12 of 360. All products under Media, Reproductive
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | 510(k) number | 2023-12-20 | Class II | Under Investigation by firm | The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage. | 994 total (481 US; 513 OUS) |
| Coopersurgical, Inc. | 510(k) number | 2023-02-13 | Class II | Labeling Change Control | It has come to CooperSurgical’s attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development. | 190 units |
| Coopersurgical, Inc. | 510(k) number | 2022-06-13 | Class II | Error in labeling | There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version. | 403 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.