FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD BBL™ Sensi-Disc™ P-Aminosalicylic Acid - 10 µg
DI: 00382902315735
·
Model: 231573
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD BBL™ Sensi-Disc™ P-Aminosalicylic Acid - 10 µg
- Primary DI
- 00382902315735
- Version / Model
- 231573
- Catalog Number
- 231573
- 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
- 2016-05-03
- Public Version
- 4
- Public Version Date
- 2023-10-06
- Public Version Status
- Update
- Public Device Record Key
- ad507545-5b73-4498-8968-d28b5627915c
- Distribution End Date
- 2021-06-17
Device Description
Disc P-Aminosalicylic Acid Pas-10 1 Ea
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
- Yes
- 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 |
|---|---|---|---|---|
| 45367 | Multiple antimycobacterial susceptibility testing kit IVD | A collection of reagents and other associated materials containing multiple susceptibility testing discs impregnated with a range of antimycobacterial agents (i.e., drugs intended for treatment and/or prevention of a mycobacterial infection) intended to be used to determine the antimicrobial susceptibility profile of a specific Mycobacterium organism, 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 | 00382902315735 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 8 Degrees Celsius