FDA UDI
In Commercial Distribution
🇺🇸 United States
Dulbecco's Phosphate Buffered Saline (D-PBS)
DI: 10190302000628
·
Model: 14040117
·
LIFE TECHNOLOGIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Dulbecco's Phosphate Buffered Saline (D-PBS)
- Primary DI
- 10190302000628
- Version / Model
- 14040117
- Company Name
- LIFE TECHNOLOGIES CORPORATION
- Labeler DUNS
- 182158873
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 5
- Public Version Date
- 2023-10-02
- Public Version Status
- Update
- Public Device Record Key
- 49cf3c76-c031-4f0d-b046-f53d5c6142ec
- Distribution End Date
- 2025-03-30
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
- 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 |
|---|---|---|---|---|
| KIP | FORMULATIONS, BALANCED SALT SOLUTIONS | Hematology | 864.2875 | 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 |
|---|---|---|---|---|---|---|
| Package | 30190302000622 | GS1 | Case | 6 | In Commercial Distribution | 2025-03-30 |
| Primary | 10190302000628 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius