FDA UDI
In Commercial Distribution
🇺🇸 United States
BD BACTEC™ FX, Instrument Bottom, Packaged
DI: 00382904413866
·
Model: 441386
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD BACTEC™ FX, Instrument Bottom, Packaged
- Primary DI
- 00382904413866
- Version / Model
- 441386
- Catalog Number
- 441386
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-25
- Public Version
- 3
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 3b818598-6e03-4350-adac-0751c723c987
Device Description
BD BACTEC™ FX, Instrument Bottom, Packaged
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
- 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 |
|---|---|---|---|---|
| MDB | SYSTEM, BLOOD CULTURING | Microbiology | 866.2560 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56739 | Blood culture analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of microorganism growth in a blood culture preparation or other clinical specimen, with or without subsequent identification of the organism. Changes in metabolite production which indicate growth may be detected using radiometric labelled substrate uptake, infrared spectrophotometric detection of CO2, fluorometric detection of fluorescent substrate uptake, photometric detection of turbidity change and/or colorimetric detection of pH induced colour change. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904413866 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K915796 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 62.2 | Centimeter | |
| Depth | 86.9 | Centimeter | |
| Height | 93.9 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 30 Degrees Celsius