ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement 70016563-00

GUDID 00347426505086

ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement

Heron Therapeutics, Inc.

Vial/bottle adaptor, non-hermetic

• Primary Device ID: 00347426505086
• NIH Device Record Key: fc9c93e2-9b45-44bc-8ee9-f38d37e068a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement
• Version Model Number: N/A
• Catalog Number: 70016563-00
• Company DUNS: 102099843
• Company Name: Heron Therapeutics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00347426505086 [Primary]

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-15
• Device Publish Date: 2024-11-07

Devices Manufactured by Heron Therapeutics, Inc.

• 00347426505086 - ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement: 2024-11-15ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement
• 00347426505086 - ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement: 2024-11-15 ZYNRELEF 10 mL Vial Access Needle (VAN) Replacement
• 00347426506083 - ZYNRELEF 20 mL Vial Access Needle (VAN) Replacement: 2024-11-15 ZYNRELEF 20 mL Vial Access Needle (VAN) Replacement
• 00347426505079 - ZYNRELEF 10 mL Vial Access Needle (VAN): 2024-10-10 ZYNRELEF 10 mL Vial Access Needle (VAN) supplied within co-packaged combination product kit
• 00347426506076 - ZYNRELEF 20 mL Vial Access Needle (VAN): 2024-10-10 ZYNRELEF 20 mL Vial Access Needle (VAN) supplied within co-packaged combination product kit
• 00347426902106 - ZYNRELEF Luer Lock Applicator: 2021-07-23
• 00347426903059 - ZYNRELEF Replacement Vented Vial Spikes: 2021-07-23 Base package contains quantity of 5 vented vial spikes.
• 00347426904087 - ZYNRELEF Replacement 12 mL Luer Lock Syringes: 2021-07-23 Base package contains quantity of 8 of the 12 mL Luer Lock Syringes.