FDA UDI
In Commercial Distribution
🇺🇸 United States
1260 Infinity II LC System Clinical Edition
DI: 05700574007225
·
Model: 1260 Infinity II LC System
·
AGILENT TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 1260 Infinity II LC System Clinical Edition
- Primary DI
- 05700574007225
- Version / Model
- 1260 Infinity II LC System
- Company Name
- AGILENT TECHNOLOGIES, INC.
- Labeler DUNS
- 084963177
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-15
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- d26b3142-5cc7-45ac-a356-d20a2a0b3229
Device Description
1260 Infinity II LC System Clinical Edition
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KIE | APPARATUS, HIGH PRESSURE LIQUID CHROMATOGRAPHY | Clinical Chemistry | 862.2260 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63101 | Liquid chromatography/mass spectrometry (LC/MS) analyser IVD | An electrically-powered automated or semi-automated laboratory instrument designed for the qualitative and/or quantitative in vitro determination of the chemical composition of a clinical specimen. The sample is introduced in a pressurized liquid and its compounds are separated based on their chemical/physical properties while interacting with a column filling; as the substances exit the column they are ionized and the resulting ions are separated according to mass using an electromagnetic field. The device is used for identification and quantification of complex substances (e.g., drugs, hormones). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05700574007225 | GS1 |
Customer Contacts
- Phone
- +1-800-227-9770
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | No Device Sizes |