HUMAN SERUM ALBUMIN 2101-1

GUDID 00859268006114

HUMAN SERUM ALBUMIN consists of human serum albumin from therapeutic-grade source material at a concentration of 100mg/ml in a sterile saline solution. HUMAN SERUM ALBUMIN is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth and embryo cryopreservation.

INVITROCARE, INCORPORATED

IVF medium

• Primary Device ID: 00859268006114
• NIH Device Record Key: 5f2f8ed4-fbfa-4889-9fa5-799137b3ba25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HUMAN SERUM ALBUMIN
• Version Model Number: 2101-1
• Catalog Number: 2101-1
• 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	00859268006114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000940

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

Devices Manufactured by INVITROCARE, INCORPORATED

• 00859268006305 - HYALURONIDSE: 2022-08-08 InVitroCare's HYALURONIDASE reagent is composed of Bovine Testes Hyaluronidase (Sigma Catalog #H4272) dissolved in a combined so
• 00859268006275 - HTF HEPES: 2021-11-12 HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. It has been fo
• 00859268006282 - SPERM WASH MEDIUM: 2021-11-12 SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in
• 00859268006008 - HTF culture medium: 2018-07-06 HTF culture medium is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. HTF u
• 00859268006015 - HTF HEPES: 2018-07-06 HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures.It has been for
• 00859268006022 - HTF HEPES: 2018-07-06 HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures.It has been for
• 00859268006039 - SPERM WASH MEDIUM: 2018-07-06 SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in
• 00859268006053 - SPERM WASH MEDIUM: 2018-07-06 SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in