FDA UDI
In Commercial Distribution
🇺🇸 United States
ProLipid Complex - 1010 ml
DI: 05407010128734
·
Model: BESP1352Q1010
·
Lonza Verviers
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ProLipid Complex - 1010 ml
- Primary DI
- 05407010128734
- Version / Model
- BESP1352Q1010
- Catalog Number
- BESP1352Q1010
- Company Name
- Lonza Verviers
- Labeler DUNS
- 370158847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-15
- Public Version
- 1
- Public Version Date
- 2025-09-23
- Public Version Status
- New
- Public Device Record Key
- 5e59217b-2b4d-4095-985e-ab266050172c
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JSK | Supplement, Culture Media | Microbiology | 866.2450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62068 | Ex vivo cell culture medium | A solution used for the ex-vivo culture of human-derived or non-human cells [e.g., T-lymphocytes, mesenchymal stem cells (MSCs), embryonic stem cells, induced pluripotent stem cells (iPSC)] or immortalised cell lines (e.g., HaCat, HeLa, HEK-293, cos-7, PC-12) intended for cell therapy applications. The solution contains a combination of nutrients, which may include amino acids, vitamins and organic salts that are vital for the growth and maintenance of the cell type/line. It is not intended for in vitro fertilization (IVF) or in vitro diagnostic applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05407010128734 | GS1 |