FDA UDI
In Commercial Distribution
🇺🇸 United States
LZI Fentanyl Level 1 Control
DI: 00850624008667
·
Model: D26785
·
LIN-ZHI INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LZI Fentanyl Level 1 Control
- Primary DI
- 00850624008667
- Version / Model
- D26785
- Catalog Number
- D26785
- Company Name
- LIN-ZHI INTERNATIONAL, INC.
- Labeler DUNS
- 840839190
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-13
- Public Version
- 1
- Public Version Date
- 2025-10-21
- Public Version Status
- New
- Public Device Record Key
- adeb6d35-f5ad-48d4-b892-faf8e4c3c648
Device Description
FEN Level 1 Control 0.5 ng/mL (1 x 5 mL)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LAS | Drug Specific Control Materials | Clinical Toxicology | 862.3280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55631 | Fentanyl IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of fentanyl in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850624008667 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius