FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Phoenix™ EMERGE AST Indicator Solution
DI: 30382902460153
·
Model: 246015
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- BD Phoenix™ EMERGE AST Indicator Solution
- Primary DI
- 30382902460153
- Version / Model
- 246015
- Catalog Number
- 246015
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-02-15
- Public Version
- 1
- Public Version Date
- 2021-02-23
- Public Version Status
- New
- Public Device Record Key
- 495b72c0-27c9-4198-b645-72d095fdafcd
Device Description
AST Indicator Emerge
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 |
|---|---|---|---|---|
| LON | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION | Microbiology | 866.1645 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43534 | Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to determine the degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) against a specific bacterial microorganism, isolated from a clinical specimen by culture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00382902460152 | GS1 | ||||
| Primary | 30382902460153 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020321 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius