Water for Irrigation, USP Sterile Grade

Basic Information

• Brand Name: Water for Irrigation, USP Sterile Grade
• Primary DI: B891WIRUSP20L0
• Version / Model: 04
• Catalog Number: WIR-USP-20L
• Company Name: INTERMOUNTAIN LIFE SCIENCES, LLC
• Labeler DUNS: 117437522
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-14
• Public Version: 1
• Public Version Date: 2020-08-24
• Public Version Status: New
• Public Device Record Key: be70965e-82ea-42c2-8bcd-ff0ab2da64a2

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	864.2220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62068	Ex vivo cell culture medium	A solution used for the ex-vivo culture of human-derived or non-human cells [e.g., T-lymphocytes, mesenchymal stem cells (MSCs), embryonic stem cells, induced pluripotent stem cells (iPSC)] or immortalised cell lines (e.g., HaCat, HeLa, HEK-293, cos-7, PC-12) intended for cell therapy applications. The solution contains a combination of nutrients, which may include amino acids, vitamins and organic salts that are vital for the growth and maintenance of the cell type/line. It is not intended for in vitro fertilization (IVF) or in vitro diagnostic applications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B891WIRUSP20L0	HIBCC

Customer Contacts

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