Sperm Fridge
Sperm Fridge is a laboratory medium that protects human semen during refrigerated storage before assisted reproduction procedures. It is intended for short-term preservation rather than…
Sperm Fridge is a laboratory medium that protects human semen during refrigerated storage before assisted reproduction procedures. It is intended for short-term preservation rather than long-term cryopreservation.
The buffered solution contains TES, Tris and dextrose, with gentamicin sulfate and recombinant human albumin. Trained laboratory professionals use it to maintain the sample before subsequent reproductive treatment.
Packaging and Processing
The medium is offered in 0.5 mL and 10 mL volumes, with the smaller volume sold in five-packs. It is prepared by aseptic filtration. Sperm Fridge’s function concerns refrigerated storage of the semen sample; the separate Sperm Freeze product serves freezing procedures.
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 | Kitazato Corporation, Japan |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K192845 |
| Record published | 2023-07-27 |
| Record revised | 2023-08-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature -20 to 0 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Sperm Fridge | In distribution | |
| Sperm Fridge | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LifeGlobal® Media | LifeGlobal Group, LLC | 93 |
| 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 |
Showing 12 of 360. All products under Media, Reproductive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260248 | 2026-04-28 |
| K251305 | 2025-08-26 |
| K200249 | 2020-10-23 |
| K193522 | 2020-08-25 |
| K192845 | 2020-08-17 |
| K190199 | 2019-09-26 |
| K182002 | 2018-10-23 |
| K171748 | 2017-12-14 |
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.