FDA UDI
In Commercial Distribution
🇺🇸 United States
BD BBL™ Sensi-Disc™ Amoxicillin with Clavulanic Acid - 20/10 µg
DI: 00382902316282
·
Model: 231628
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD BBL™ Sensi-Disc™ Amoxicillin with Clavulanic Acid - 20/10 µg
- Primary DI
- 00382902316282
- Version / Model
- 231628
- Catalog Number
- 231628
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-03
- Public Version
- 4
- Public Version Date
- 2023-09-01
- Public Version Status
- Update
- Public Device Record Key
- 8dd67b49-9267-4789-b4e3-487fbdca6c64
Device Description
BD BBL™ Sensi-Disc™ Amoxicillin/Clavulanic Acid 20/10 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 |
|---|---|---|---|---|
| 63834 | Antibacterial susceptibility testing disc IVD | A susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using a disc diffusion method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382902316282 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K842253 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 8 Degrees Celsius