FDA UDI
In Commercial Distribution
🇺🇸 United States
CHO Trace Element Solution (BESP807)
DI: 00840075404064
·
Model: 04-1163Q
·
Lonza Walkersville, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CHO Trace Element Solution (BESP807)
- Primary DI
- 00840075404064
- Version / Model
- 04-1163Q
- Catalog Number
- 04-1163Q
- Company Name
- Lonza Walkersville, Inc.
- Labeler DUNS
- 609095955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-05
- Public Version
- 1
- Public Version Date
- 2023-05-15
- Public Version Status
- New
- Public Device Record Key
- ecfbfd8c-e4e8-4e5b-82fb-0d849f567881
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 |
|---|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | Hematology | 864.2220 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58567 | Cell culture medium IVD | A liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840075404064 | GS1 |