Water for Assisted Reproductive Technologies (A.R.T.) Use 9307

GUDID 00857515006078

Water for Assisted Reproductive Technologies (A.R.T.) Use Custom package

FUJIFILM IRVINE SCIENTIFIC, INC.

IVF medium

• Primary Device ID: 00857515006078
• NIH Device Record Key: 8d5cc564-2252-49ed-a59d-ac41700f80f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Water for Assisted Reproductive Technologies (A.R.T.) Use
• Version Model Number: 9307-50ML
• Catalog Number: 9307
• Company DUNS: 057475246
• Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.
• 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: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8004375706
• Email: tmrequest@irvinesci.com

Device Dimensions

• Total Volume: 50 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857515006078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011598

FDA Product Code

• MTW: System,Water,Reproduction,Assisted,And Purification

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-13
• Device Publish Date: 2016-09-10

Devices Manufactured by FUJIFILM IRVINE SCIENTIFIC, INC.

• 00893727002002 - Oil for Embryo Culture: 2025-06-16 Oil for Embryo Culture
• 00893727002019 - PBS 1X - Dulbecco's Phosphate Buffered Saline Solution: 2025-06-16 PBS 1X Dulbecco's
• 00893727002071 - Sperm Washing Medium: 2025-06-16 Sperm Washing Medium
• 00893727002088 - Sperm Washing Medium: 2025-06-16 Sperm Washing Medium
• 00893727002101 - Human Serum Albumin Solution: 2025-06-16 Human Serum Albumin Solution
• 00893727002125 - Hyaluronidase Solution: 2025-06-16 Hyaluronidase
• 00893727002163 - 7% PVP Solution with HSA: 2025-06-16 Polyvinylpyrrolidone (PVP) Solution with HSA - 7%
• 00893727002170 - 10% PVP Solution with HSA: 2025-06-16 Polyvinylpyrrolidone (PVP) Solution with HSA - 10%