HTF culture medium 2001

GUDID 00859268006008

HTF culture medium is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. HTF uses a sodium bicarbonate buffering system and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation.

INVITROCARE, INCORPORATED

IVF medium

• Primary Device ID: 00859268006008
• NIH Device Record Key: 7e753566-97fd-4b32-8ea4-c2a25936b728
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HTF culture medium
• Version Model Number: 2001
• Catalog Number: 2001
• 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	00859268006008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993484

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: 2018-07-06HTF culture medium is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. HTF uses a sodium bicarbonate buffering system and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation.
• 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