FDA UDI
In Commercial Distribution
🇺🇸 United States
USB-STICK MAGELLAN V 7.5
DI: 09120052071504
·
Model: 30231095 00
·
Tecan Austria GmbH
Product Codes
1
GMDN Terms
1
Identifiers
7
Pkg Device Count
1
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Basic Information
- Brand Name
- USB-STICK MAGELLAN V 7.5
- Primary DI
- 09120052071504
- Version / Model
- 30231095 00
- Catalog Number
- 30231095
- Company Name
- Tecan Austria GmbH
- Labeler DUNS
- 301237509
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-07
- Public Version
- 3
- Public Version Date
- 2025-02-13
- Public Version Status
- Update
- Public Device Record Key
- ab84a6b7-d48a-4151-8cdf-388a7868bcb7
Device Description
This media contains V 7.5 of the following registered Medical Devices: (DI)09120052070996 (SOFTWARE MAGELLAN V 7.X), (DI)09120052071009 (SOFTWARE MAGELLAN TRACKER V 7.X)
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | Clinical Chemistry | 862.2100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43472 | Laboratory instrument/analyser application software IVD | An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09120052071504 | GS1 | ||||
| Package | 09120052071511 | GS1 | Plastic Box | 2 | In Commercial Distribution | |
| Package | 09120052071528 | GS1 | Plastic Box | 2 | In Commercial Distribution | |
| Package | 09120052071535 | GS1 | Plastic Box | 5 | In Commercial Distribution | |
| Package | 09120052071542 | GS1 | Plastic Box | 5 | In Commercial Distribution | |
| Package | 09120052071559 | GS1 | Plastic Box | 1 | In Commercial Distribution | |
| Package | 09120052071566 | GS1 | Plastic Box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +18003525128
- [email protected]