FDA UDI
In Commercial Distribution
🇺🇸 United States
BD BBL™ TB Decolorizer
DI: 30382902125175
·
Model: 212517
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- BD BBL™ TB Decolorizer
- Primary DI
- 30382902125175
- Version / Model
- 212517
- Catalog Number
- 212517
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2018-05-25
- Public Version
- 6
- Public Version Date
- 2026-03-18
- Public Version Status
- Update
- Public Device Record Key
- f2798293-b0e4-47a0-a448-cd7582d603d2
Device Description
BD BBL™ TB Decolorizer, 250 mL
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 |
|---|---|---|---|---|
| JTS | Stains, microbiologic | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43587 | Biological stain IVD | A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30382902125175 | GS1 | ||||
| Unit of Use | 00382902125174 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 250 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- P403+P235 Store in a well-ventilated place. Keep cool.
- Type
- Special Storage Condition, Specify
- Special Conditions
- P405 – Store locked up.
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius