FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD BBL™ Sensi-Disc™ Voriconazole - 1 µg
DI: 00382902322023
·
Model: 232202
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD BBL™ Sensi-Disc™ Voriconazole - 1 µg
- Primary DI
- 00382902322023
- Version / Model
- 232202
- Catalog Number
- 232202
- 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
- 2016-05-19
- Public Version
- 5
- Public Version Date
- 2023-10-12
- Public Version Status
- Update
- Public Device Record Key
- bf9567cf-ae69-445e-b475-b55ae4b9ea2c
- Distribution End Date
- 2021-06-17
Device Description
BD BBL™ Sensi-Disc™ Voriconazole - 1 µg
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JTN | SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL | Microbiology | 866.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45299 | Multiple antifungal susceptibility testing kit IVD | A collection of reagents and other associated materials containing multiple susceptibility testing discs impregnated with a range of antifungal/antimycotic agents (i.e., drugs intended for treatment and/or prevention of a fungal infection) intended to be used to determine the susceptibility profile of a specific fungal or yeast 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 | 00382902322023 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082272 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 8 Degrees Celsius