FDA UDI
In Commercial Distribution
🇺🇸 United States
USB-STICK MAGELLAN PRO V7.4
DI: 09120052071351
·
Model: 30220141 00
·
Tecan Austria GmbH
Product Codes
1
GMDN Terms
1
Identifiers
7
Pkg Device Count
1
Basic Information
- Brand Name
- USB-STICK MAGELLAN PRO V7.4
- Primary DI
- 09120052071351
- Version / Model
- 30220141 00
- Catalog Number
- 30220141
- Company Name
- Tecan Austria GmbH
- Labeler DUNS
- 301237509
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-17
- Public Version
- 2
- Public Version Date
- 2023-02-27
- Public Version Status
- Update
- Public Device Record Key
- 044c2bd0-3c6e-4d40-a23a-3df5ae01dfd5
Device Description
This media contains V 7.4 of the following registered Medical Devices: (DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X), (DI)09120052070910 (SOFTWARE MAGELLAN PRO 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 | 09120052071351 | GS1 | ||||
| Package | 09120052071368 | GS1 | Carton Box | 2 | In Commercial Distribution | |
| Package | 09120052071375 | GS1 | Carton Box | 2 | In Commercial Distribution | |
| Package | 09120052071382 | GS1 | Carton Box | 1 | In Commercial Distribution | |
| Package | 09120052071399 | GS1 | Carton Box | 1 | In Commercial Distribution | |
| Package | 09120052071450 | GS1 | Plastic Box | 2 | In Commercial Distribution | |
| Package | 09120052071467 | GS1 | Plastic Box | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- +18003525128
- [email protected]