V-PVP

GUDID 04260650071034

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.

VITROMED GmbH

IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium IVF medium

• Primary Device ID: 04260650071034
• NIH Device Record Key: 6fa9bdda-2b09-49fa-81d4-20defa20db5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-PVP
• Version Model Number: V-PVP-7
• Company DUNS: 315234102
• Company Name: VITROMED GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260650071034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232125

FDA Product Code

• MQL: Media, Reproductive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-13
• Device Publish Date: 2024-05-04

Devices Manufactured by VITROMED GmbH

• 04260650071034 - V-PVP: 2024-05-13V-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.
• 04260650071034 - V-PVP: 2024-05-13 V-PVP is a ready-to-use pharma grade polyvinylpyrrolidone (PVP) solution containing HEPES buffered Human Tubal Fluid (HTF) mediu
• 04260650071836 - V-HYADASE: 2023-07-24 V-HYADASE is a ready-to-use media for the denudation of oocytes prior to the intracytoplasmic sperm injection (ICSI). It contain
• 04260650071805 - V-SPERM WASH: 2023-03-08 V-SPERM WASH is an assisted reproduction medium intended for washing ofspermatozoa, the isolation of motile viable sperm by swim
• 04260531792249 - V-CENTERWELL-60: 2022-12-01 IVF Labware are ready-to-use plastic disposables.
• 04260531792270 - V-CULTUREDISH-60: 2022-12-01 IVF Labware are ready-to-use plastic disposables.
• 04260531792294 - V-CULTUREDISH-90: 2022-12-01 IVF Labware are ready-to-use plastic disposables.
• 04260531792317 - V-CULTUREDISH-35: 2022-12-01 IVF Labware are ready-to-use plastic disposables.
• 04260531792393 - V-ICSIDISH-50: 2022-12-01 IVF Labware are ready-to-use plastic disposables.