ZYNRELEF 20 mL Vial Access Needle (VAN)

Basic Information

• Brand Name: ZYNRELEF 20 mL Vial Access Needle (VAN)
• Primary DI: 00347426506076
• Version / Model: N/A
• Catalog Number: 12027-325-32
• Company Name: Heron Therapeutics, Inc.
• Labeler DUNS: 102099843
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-02
• Public Version: 1
• Public Version Date: 2024-10-10
• Public Version Status: New
• Public Device Record Key: c34b9c38-8f94-43cc-8cf3-cbd45b374b94

Device Description

ZYNRELEF 20 mL Vial Access Needle (VAN) supplied within co-packaged combination product kit

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
60539	Vial/bottle adaptor, non-hermetic	A device intended to be fitted to a vial or bottle to enable the removal of its contents, (e.g., medication, nutritional solution for enteral feeding) into a syringe, for subsequent administration to a patient. It is typically a housing with a barbed connection or spike that attaches to or replaces the container lid, and a small bore connection (typically ENFit or a Luer); it does not allow for pressure equalization/airtight transfer of contents. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00347426506076	GS1