FDA UDI
In Commercial Distribution
🇺🇸 United States
MBT-CA System BD
DI: 04251204325710
·
Model: 8604736
·
Bruker Daltonik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MBT-CA System BD
- Primary DI
- 04251204325710
- Version / Model
- 8604736
- Catalog Number
- 8604736
- Company Name
- Bruker Daltonik GmbH
- Labeler DUNS
- 318387958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-25
- Public Version
- 4
- Public Version Date
- 2022-09-26
- Public Version Status
- Update
- Public Device Record Key
- 7443f342-0406-4893-8d31-0bf9226eb6ed
Device Description
Biotyper system for clinical use in the USA, for Becton Dickinson.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates | Microbiology | 866.3361 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61643 | Microbial identification mass spectrometry system IVD | An assembly of mains electricity (AC-powered) devices intended to be used for the qualitative detection and identification of microbial species (bacteria, fungi) in a clinical specimen using mass spectrometry. It typically consists of a sample handling/preparation unit, a mass spectrometry instrument, and a server with software intended to analyse results and compare the produced spectra with information in a remote database to identify and report the microbial species in the specimen. The system operates with reduced technician involvement and automation of some, but not all, procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04251204325710 | GS1 |
Customer Contacts
- Phone
- +1(877)442-2231
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 6560 ft operating altitude
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- non-condensing at 91F
- Type
- Handling Environment Temperature
- Temperature Range
- 61 – 91 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 85 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- non-condensing, for reference only
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- High: 79500 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 75 Percent (%) Relative Humidity