Hypure Oil Light 500mL 93829

GUDID 04573316381362

KITAZATO CORPORATION

IVF medium kit

• Primary Device ID: 04573316381362
• NIH Device Record Key: 62d75ab8-3ea6-4a9e-a3e8-83652ee058c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hypure Oil Light 500mL
• Version Model Number: MOLHUS-500
• Catalog Number: 93829
• Company DUNS: 711091157
• Company Name: KITAZATO CORPORATION
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 8 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04573316381362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160142

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: 2
• Public Version Date: 2023-05-31
• Device Publish Date: 2023-01-13

Devices Manufactured by KITAZATO CORPORATION

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• 14573316385503 - VS(Vitrification Solution) Pack 4 vials: 2024-10-25 VS(Vitrification Solution) Pack of 4x1.5ml vials
• 14573316385510 - BS(Basic Solution) Pack 4 vials 4ml: 2024-10-25 BS(Basic Solution) Pack of 4x4ml vials
• 14573316385527 - ES(Equilibration Solution) Pack 4 vials 4ml: 2024-10-25 ES(Equilibration Solution) Pack 4x4ml vials
• 14573316385534 - VS(Vitrification Solution) Pack 4 vials 4ml: 2024-10-25 VS(Vitrification Solution) Pack of 4x4ml vials
• 14573316385558 - DS(Diluent Solution) Pack 4 vials: 2024-10-25 DS(Diluent Solution) Pack of 4x4ml vials
• 14573316385565 - WS(Washing Solution) Pack 4 vials: 2024-10-25 WS(Washing Solution) Pack of 4x4ml vials