10% PVP Solution with HSA

Basic Information

• Brand Name: 10% PVP Solution with HSA
• Primary DI: 00893727002170
• Version / Model: 90123-5X0.5mL
• Catalog Number: 90123
• Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.
• Labeler DUNS: 057475246
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-10
• Public Version: 4
• Public Version Date: 2019-02-13
• Public Version Status: Update
• Public Device Record Key: 3d26123d-c24a-4443-b505-d5ebff667268

Device Description

Polyvinylpyrrolidone (PVP) Solution with HSA - 10%

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQL	Media, Reproductive	Obstetrics/Gynecology	884.6180	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46553	Assisted reproduction microtool	A dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00893727002170	GS1
Unit of Use	18937270021703	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K991343	000

Device Sizes

Type	Value	Unit	Text
Total Volume	0.5	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius