Hypure Oil Heavy 100mL 93628

GUDID 14573316381376

KITAZATO CORPORATION

IVF medium kit

• Primary Device ID: 14573316381376
• NIH Device Record Key: ef938bde-cd6c-44b2-9d18-32c866ce82df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hypure Oil Heavy 100mL
• Version Model Number: MOHVUS-100
• Catalog Number: 93628
• 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	04573316381379 [Primary]
GS1	14573316381376 [Package]; Contains: 04573316381379; Package: [1 Units]; In Commercial Distribution

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

On-Brand Devices [Hypure Oil Heavy 100mL]

• 14582231460349: MOHV-100
• 14573316381376: MOHVUS-100