Hypure Oil Heavy 500mL 93629

GUDID 04573316381386

KITAZATO CORPORATION

IVF medium kit

• Primary Device ID: 04573316381386
• NIH Device Record Key: 40bf52cf-4e93-47a3-80e9-adfbbf67f663
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hypure Oil Heavy 500mL
• Version Model Number: MOHVUS-100
• Catalog Number: 93629
• 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	04573316381386 [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

• 14580745043782 - ET CATHETER RYDEN: 2025-09-25
• 14580745043904 - ET CATHETER RYDEN: 2025-09-25
• 14580745044239 - ET CATHETER RYDEN: 2025-09-25
• 14580745044246 - ET CATHETER RYDEN: 2025-09-25
• 14573316384773 - Ultra-Fast Warm: 2025-09-05
• 14573316385107 - Ultra-Fast Vitri: 2025-09-05
• 14573316385114 - Ultra-Fast Vitri: 2025-09-05
• 14573316385978 - Ultra-Fast Vitri: 2025-09-05