FDA UDI
In Commercial Distribution
🇺🇸 United States
BD BACTEC™ Myco/F Lytic Culture Vials
DI: 00382904422882
·
Model: 442288
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BD BACTEC™ Myco/F Lytic Culture Vials
- Primary DI
- 00382904422882
- Version / Model
- 442288
- Catalog Number
- 442288
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-07
- Public Version
- 3
- Public Version Date
- 2025-11-24
- Public Version Status
- Update
- Public Device Record Key
- f407c887-cae9-43f3-b49f-c7d06ae2dbc8
Device Description
BD BACTEC™ Myco/F Lytic Culture Vials
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 |
|---|---|---|---|---|
| MDB | System, blood culturing | Microbiology | 866.2560 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58556 | Culture medium antimicrobial supplement IVD | A culture medium supplement containing one or multiple antimicrobials that is intended to be used to suppress or inhibit the growth of native or resident microorganisms present in a clinical specimen to enhance recovery, isolation, and/or growth of pathogenic organisms. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904422882 | GS1 | ||||
| Package | 30382904422883 | GS1 | Shelfpack | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, handle with care
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from light