FDA UDI
Not in Commercial Distribution
🇺🇸 United States
KnockOut™ SR Xenofree CTS™
DI: 10190302002530
·
Model: 12618012
·
LIFE TECHNOLOGIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- KnockOut™ SR Xenofree CTS™
- Primary DI
- 10190302002530
- Version / Model
- 12618012
- Company Name
- LIFE TECHNOLOGIES CORPORATION
- Labeler DUNS
- 118793157
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 6
- Public Version Date
- 2020-08-13
- Public Version Status
- Update
- Public Device Record Key
- 4bcd04ee-a7da-4cd7-b41c-d13433d4d887
- Distribution End Date
- 2020-08-12
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDS | MEDIA, CULTURE, EX VIVO, TISSUE AND CELL | Gastroenterology, Urology | 876.5885 | 2 |
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 | 10190302002530 | GS1 | ||||
| Package | 30190302002534 | GS1 | Each | 20 | Not in Commercial Distribution | 2020-08-12 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100616 | 000 |