FDA UDI
In Commercial Distribution
🇺🇸 United States
BD BBL™ Mueller Hinton Agar with 5% Sheep Blood
DI: 10382902218019
·
Model: 221801
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4
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Basic Information
- Brand Name
- BD BBL™ Mueller Hinton Agar with 5% Sheep Blood
- Primary DI
- 10382902218019
- Version / Model
- 221801
- Catalog Number
- 221801
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2016-12-21
- Public Version
- 5
- Public Version Date
- 2025-05-20
- Public Version Status
- Update
- Public Device Record Key
- d9be56ae-844c-420b-af38-e36959c5d7a2
Device Description
BD BBL™ Mueller Hinton Agar with 5% Sheep Blood, Pkg. of 24, 150 mm-style plates
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 |
|---|---|---|---|---|
| JTZ | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH | Microbiology | 866.1700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58640 | Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood | A non-selective Mueller-Hinton culture medium containing defibrinated sheep blood intended to be used to perform diagnostic antimicrobial susceptibility testing on streptococci and other organisms requiring blood for growth that are isolated from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30382902218013 | GS1 | Shelfpack | 6 | In Commercial Distribution | |
| Primary | 10382902218019 | GS1 | ||||
| Unit of Use | 00382902218012 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K960420 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 150 | Millimeter | |
| Depth | 15 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- This way up
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, handle with care
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from light