ZIMHI

GUDID 10384571140028

ZIMHI® (naloxone HCl Injection, USP) 5 mg/0.5 mL FOR INTERMUSCULAR OR SUBCUTANEOUS INJECTION

ZMI Pharma Inc

Prefilled syringe/needle

• Primary Device ID: 10384571140028
• NIH Device Record Key: 7ce30c7a-db72-4ae0-bcbf-9aeca9a49740
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZIMHI
• Version Model Number: 1
• Company DUNS: 119298269
• Company Name: ZMI Pharma Inc
• Device Count: 2
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384571140021 [Primary]
GS1	00384571140113 [Unit of Use]
GS1	10384571140028 [Package]; Contains: 00384571140113; Package: Shipper Box [12 Units]; In Commercial Distribution
GS1	20384571140025 [Package]; Package: Pallet [280 Units]; In Commercial Distribution

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-26
• Device Publish Date: 2026-01-16