FDA UDI
In Commercial Distribution
🇺🇸 United States
ZIMHI
DI: 00384571140021
·
Model: 1
·
ZMI Pharma Inc
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
2
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Basic Information
- Brand Name
- ZIMHI
- Primary DI
- 00384571140021
- Version / Model
- 1
- Company Name
- ZMI Pharma Inc
- Labeler DUNS
- 119298269
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2026-01-16
- Public Version
- 1
- Public Version Date
- 2026-01-26
- Public Version Status
- New
- Public Device Record Key
- 7ce30c7a-db72-4ae0-bcbf-9aeca9a49740
Device Description
ZIMHI® (naloxone HCl Injection, USP) 5 mg/0.5 mL FOR INTERMUSCULAR OR SUBCUTANEOUS INJECTION
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65413 | Prefilled syringe/needle | A device consisting of a calibrated barrel (cylinder) with plunger and an attached needle, which is prefilled with a pharmaceutical (e.g., insulin, anti-rheumatic drug), intended to be used by a patient or carer for subcutaneous or intramuscular manual injection of a single dose of the medication/pharmaceutical; it is not intended for anaesthesia/nerve block. Procedural supportive devices (e.g., dressings, antiseptic wipes) may be included with the syringe. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10384571140028 | GS1 | Shipper Box | 12 | In Commercial Distribution | |
| Unit of Use | 00384571140113 | GS1 | ||||
| Package | 20384571140025 | GS1 | Pallet | 280 | In Commercial Distribution | |
| Primary | 00384571140021 | GS1 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 68 – 77 Degrees Fahrenheit