SPERM WASH MEDIUM 2003-K2

GUDID 00859268006077

SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.

INVITROCARE, INCORPORATED

IVF medium

• Primary Device ID: 00859268006077
• NIH Device Record Key: 4ef39785-3acf-443a-936d-59a56ca9ef88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPERM WASH MEDIUM
• Version Model Number: 2003-K2
• Catalog Number: 2003-K2
• Company DUNS: 190094230
• Company Name: INVITROCARE, INCORPORATED
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859268006077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000989

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: 2016-09-24

On-Brand Devices [SPERM WASH MEDIUM]

• 00859268006084: SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum al
• 00859268006077: SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum al
• 00859268006060: SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum al
• 00859268006053: SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum al
• 00859268006039: SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum al
• 00859268006282: SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum al