FDA UDI
In Commercial Distribution
🇺🇸 United States
PRAS BRU PEA BBE LKV Convenience Pack
DI: 00810048901333
·
Model: AS-444
·
ANAEROBE SYSTEMS
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PRAS BRU PEA BBE LKV Convenience Pack
- Primary DI
- 00810048901333
- Version / Model
- AS-444
- Catalog Number
- AS-444
- Company Name
- ANAEROBE SYSTEMS
- Labeler DUNS
- 021192653
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-01
- Public Version
- 1
- Public Version Date
- 2020-05-11
- Public Version Status
- New
- Public Device Record Key
- 61eba992-0ccf-4791-8644-821a9af379d3
Device Description
AS-444 BRU, PEA, BBE, and LKV Convenience Pack - Includes 1 Brucella Blood Agar (BRU), 1 Phenylethyl Alcohol Blood Agar, 1 Bacteroides Bile Esculin Agar (BBE), and 1 Laked Brucella Blood Agar with Kanamycin and Vancomycin (LKV). Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. BRU is opaque burgundy red. PEA is opaque red. BBE is transparent yellow/green. LKV is transparent red. 4 plates per pack.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| KZI | Culture Media, Enriched | Microbiology | 866.2330 | 1 |
| JSH | Culture Media, Non-Selective And Differential | Microbiology | 866.2320 | 1 |
| JSJ | Culture Media, Selective And Non-Differential | Microbiology | 866.2360 | 1 |
| JSI | Culture Media, Selective And Differential | Microbiology | 866.2360 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62106 | Multiple formulation agar culture medium IVD | A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810048901333 | GS1 |
Customer Contacts
- Phone
- 1-800-443-3108
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius