Nidacon PSK-020

GUDID 07350025610009

The product is intended to be used for the separation and purification of spermatozoa by density gradient centrifugation of human semen samples, where

Nidacon International AB

Spermatozoa/semen motility medium supplement

• Primary Device ID: 07350025610009
• NIH Device Record Key: 0f841437-03c1-4639-b396-e636e1d3bb07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nidacon
• Version Model Number: PureSperm® 40/80
• Catalog Number: PSK-020
• Company DUNS: 631825841
• Company Name: Nidacon International AB
• 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

Customer Support Contacts

• Phone: +46317030630
• Email: contact@nidacon.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350025610009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002623

FDA Product Code

• MQL: Media, Reproductive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-15

On-Brand Devices [Nidacon]

• 07350025610399: The product is intended to be used for the separation and purification of spermatozoa by density
• 07350025610252: Nidacon's ThermoBlast Thaw Kit for intended to be used with Nidacon’s VitriBlast for optimal r
• 07350025610245: VitriBlast is intended for ultra-rapid freezing of human blastocysts. This kit is designed for u
• 07350025610238: The product is intended to be used for the separation and purification of spermatozoa by density
• 07350025610191: An optimized staining technique for assessment of sperm vitality. For use with Assisted Reprodu
• 07350025610184: The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Ass
• 07350025610177: The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Ass
• 07350025610153: The product is intended to be used as a cryopreservative for protecting human sperm during cryop
• 07350025610146: SpermCatch is a medium designed to modulate sperm motility in a physiological manner, to facilit
• 07350025610139: The product is intended to be used for solution for re-suspending sperm after density gradient
• 07350025610092: The product is intended to be used for the separation and purification of spermatozoa by density
• 07350025610085: The product is intended to be used as an accessory for the separation and purification of human
• 07350025610078: The product is intended to be used as an accessory for the separation and purification of human
• 07350025610061: The product is intended to be used for diluting PureSperm® sperm separation medium to prepare
• 07350025610054: The product is intended to be used for the separation and purification of spermatozoa by density
• 07350025610047: The product is intended to be used for the separation and purification of spermatozoa by density
• 07350025610030: The product is intended to be used for the separation and purification of spermatozoa by density
• 07350025610023: The product is intended to be used for the separation and purification of spermatozoa by density
• 07350025610016: The product is intended to be used for the separation and purification of spermatozoa by density
• 07350025610009: The product is intended to be used for the separation and purification of spermatozoa by density