7% PVP Solution with HSA 90121

GUDID 00893727002163

Polyvinylpyrrolidone (PVP) Solution with HSA - 7%

FUJIFILM IRVINE SCIENTIFIC, INC.

Assisted reproduction microtool

• Primary Device ID: 00893727002163
• NIH Device Record Key: 66f2cabb-30d7-4515-b9ad-f0f10ad78da1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 7% PVP Solution with HSA
• Version Model Number: 90121-5X0.5mL
• Catalog Number: 90121
• Company DUNS: 057475246
• Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.
• Device Count: 5
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter
• Total Volume: 0.5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00893727002163 [Primary]
GS1	18937270021635 [Unit of Use]

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: 5
• Public Version Date: 2025-06-16
• Device Publish Date: 2016-09-10

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• 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: 2025-06-16Polyvinylpyrrolidone (PVP) Solution with HSA - 7%
• 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%