FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sprinter XL (model 240 samples, IFA incl. incubator)
DI: 04049016109655
·
Model: YG 0033-0101-24
·
EUROIMMUN Medizinische Labordiagnostika AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sprinter XL (model 240 samples, IFA incl. incubator)
- Primary DI
- 04049016109655
- Version / Model
- YG 0033-0101-24
- Company Name
- EUROIMMUN Medizinische Labordiagnostika AG
- Labeler DUNS
- 322209263
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2022-11-15
- Public Version Status
- Update
- Public Device Record Key
- 6a56afb5-83e2-41a5-af8d-3b326e1e9399
- Distribution End Date
- 2022-05-26
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 |
|---|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | Clinical Chemistry | 862.2750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15133 | Laboratory diluter | A mains electricity (AC-powered) laboratory instrument designed to make reliable and accurate dilutions of a sample and reagent (or diluent) solutions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049016109655 | GS1 |