FDA UDI
In Commercial Distribution
🇺🇸 United States
BD BACTEC™ MGIT™ 960 STR 4.0 Kit
DI: 00382902451259
·
Model: 245125
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD BACTEC™ MGIT™ 960 STR 4.0 Kit
- Primary DI
- 00382902451259
- Version / Model
- 245125
- Catalog Number
- 245125
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-19
- Public Version
- 5
- Public Version Date
- 2023-09-08
- Public Version Status
- Update
- Public Device Record Key
- f379eff3-ffad-40f9-8f3c-105617e373b6
Device Description
Kit Bactec 960 Streptomycin 4.0 Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MJA | SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL | Microbiology | 866.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37300 | Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit | A collection of reagents or test strips, and other associated materials, containing multiple antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) at specified concentration gradients, intended to be used to determine the degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antibacterials against a specific bacterial microorganism, isolated from a clinical specimen by culture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382902451259 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K003062 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius