Nidacon
The product is intended to be used as an accessory for the separation and purification of human spermatozoa by density gradient centrifugation of human semen samples, where the prepared…
The product is intended to be used as an accessory for the separation and purification of human spermatozoa by density gradient centrifugation of human semen samples, where the prepared sperm are used for IntraUterine Insemination (IUI) and for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies
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 | Nidacon International AB, Sweden |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K002623 |
| Record published | 2017-12-15 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PureSperm® 40/80 | In distribution | |
| PureSperm® 80 | In distribution | |
| ThermoBlast™ Kit | In distribution | |
| Sperm CryoProtec™ | In distribution | |
| PureSperm® 40 | In distribution | |
| PureSperm® 90 | In distribution | |
| PureSperm® Wash | In distribution | |
| PureSperm® 100 | In distribution | |
| VitriBlast™ Kit | In distribution | |
| PureSperm® Wash | In distribution | |
| PureSperm® Buffer | In distribution | |
| SpermCatch | In distribution | |
| NidOil™ | In distribution | |
| SpermAssist™ | In distribution | |
| PureSperm® Wash | In distribution | |
| PureSperm® 100 | In distribution | |
| PureSperm® 100K | In distribution | |
| NidOil™ | In distribution | |
| PureSperm® SpeediKit | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K092107 | 2010-06-15 |
| K023206 | 2002-11-08 |
| K022443 | 2002-08-28 |
| K011607 | 2001-08-10 |
| K012123 | 2001-08-03 |
| K011606 | 2001-07-12 |
| K011346 | 2001-06-28 |
| K002630 | 2000-11-21 |
| K002623 | 2000-11-20 |
| K984172 | 1999-01-14 |
| K980814 | 1998-06-23 |
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.