Sepa Sperm Wash Solution 92149

GUDID 04573316381317

Sepa Sperm Wash Solution with Gentamicin, 100mL

KITAZATO CORPORATION

IVF medium

• Primary Device ID: 04573316381317
• NIH Device Record Key: 72b0d0ab-150c-4b0b-b042-1e0e546c0797
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sepa Sperm Wash Solution
• Version Model Number: Sepa Sperm Wash Solution
• Catalog Number: 92149
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04573316381317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190199

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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• 14573316385107 - Ultra-Fast Vitri: 2025-09-05
• 14573316385114 - Ultra-Fast Vitri: 2025-09-05
• 14573316385978 - Ultra-Fast Vitri: 2025-09-05
• 14573316385985 - Ultra-Fast Vitri: 2025-09-05
• 14573316386012 - Ultra-Fast Vitri: 2025-09-05
• 14573316386029 - Ultra-Fast Vitri: 2025-09-05
• 14573316386173 - ES(Equilibration Solution) Pack 4 vials: 2024-12-03 ES(Equilibration Solution) Pack 4x1.5ml vials