FDA UDI
In Commercial Distribution
🇺🇸 United States
BD BBL™ Lim Broth
DI: 30382902962664
·
Model: 296266
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- BD BBL™ Lim Broth
- Primary DI
- 30382902962664
- Version / Model
- 296266
- Catalog Number
- 296266
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-05-25
- Public Version
- 3
- Public Version Date
- 2023-11-22
- Public Version Status
- Update
- Public Device Record Key
- 7ce49324-6534-49d1-8d3f-e42f2da60f49
Device Description
BD BBL™ Lim Broth
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 |
|---|---|---|---|---|
| JSD | CULTURE MEDIA, SELECTIVE BROTH | Microbiology | 866.2360 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58684 | Differential/selective broth culture medium IVD | A broth culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing in the same medium. It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30382902962664 | GS1 | ||||
| Unit of Use | 00382902962663 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K833759 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius