V-PVP
V-PVP is a ready-to-use solution that helps immobilize and isolate individual sperm cells before intracytoplasmic sperm injection. It is used as a laboratory medium during assisted…
V-PVP is a ready-to-use solution that helps immobilize and isolate individual sperm cells before intracytoplasmic sperm injection. It is used as a laboratory medium during assisted reproduction procedures.
The formulation contains 7 percent polyvinylpyrrolidone with human serum albumin, physiological salts, HEPES-buffered human tubal fluid, pyruvate, lactate, glucose and gentamicin.
Listed Item
V-PVP is a ready-to-use pharma grade polyvinylpyrrolidone (PVP) solution containing HEPES buffered Human Tubal Fluid (HTF) medium and Human Serum Albumin (HSA). V-PVP is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.
Preparation and Supply
The solution is sterile filtered and aseptically filled, with 0.5 mL supplied in a 2 mL bottle. It is intended to support single-sperm handling before injection rather than serve as a general culture medium. The documented storage period is one year unopened and up to seven days after opening when handled and stored as specified.
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 | Vitromed GmbH, Germany |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K232125 |
| Record published | 2024-05-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V-PVP-7 | 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 |
|---|---|
| K241833 | 2025-03-21 |
| K240176 | 2024-09-13 |
| K232125 | 2024-03-20 |
| K222606 | 2023-05-26 |
| K223117 | 2023-01-31 |
| K193285 | 2020-11-20 |
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.