FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD BACTEC™ Plus Aerobic/F Culture Vials
DI: 00382904421922
·
Model: 442192
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BD BACTEC™ Plus Aerobic/F Culture Vials
- Primary DI
- 00382904421922
- Version / Model
- 442192
- Catalog Number
- 442192
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-25
- Public Version
- 3
- Public Version Date
- 2023-10-30
- Public Version Status
- Update
- Public Device Record Key
- c78f07bc-c258-4f1e-b99c-a52e05a19e46
- Distribution End Date
- 2023-06-30
Device Description
Bactec Plus Aerobic/F 50/Pk F/G
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 |
|---|---|---|---|---|
| 58543 | Blood culture broth kit IVD | A collection of two or more bottles containing broth culture medium, with or without additional supplements and/or adsorbent compounds, intended to be used for the collection, preservation, and/or transport of a clinical blood specimen for culture, analysis, and/or other investigation using a manual or automated method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30382904421923 | GS1 | Shelfpack | 50 | Not in Commercial Distribution | 2023-06-30 |
| Primary | 00382904421922 | GS1 | ||||
| Package | 60382904421924 | GS1 | US pallet | 70 | Not in Commercial Distribution | 2023-06-30 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 30 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius