FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Phoenix™ PMIC-108
DI: 30382904484188
·
Model: 448418
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- BD Phoenix™ PMIC-108
- Primary DI
- 30382904484188
- Version / Model
- 448418
- Catalog Number
- 448418
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-08-30
- Public Version
- 5
- Public Version Date
- 2023-10-25
- Public Version Status
- Update
- Public Device Record Key
- 9cf969d1-9f65-412f-ae79-4974d7c06c79
Device Description
Panel Phoenix Pmic 108
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 |
|---|---|---|---|---|
| 43554 | Bacterial species culture isolate identification/antimicrobial susceptibility profile 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 identification and antimicrobial susceptibility profile of bacteria species isolated from a clinical specimen by culture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 30382904484188 | GS1 | ||||
| Unit of Use | 00382904484187 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020322 | 000 |
| K021954 | 000 |
| K022172 | 000 |
| K023273 | 000 |
| K023301 | 000 |
| K024152 | 000 |
| K030677 | 000 |
| K031306 | 000 |
| K031589 | 000 |
| K031679 | 000 |
| K032131 | 000 |
| K033784 | 000 |
| K033907 | 000 |
| K040006 | 000 |
| K040106 | 000 |
| K040716 | 000 |
| K050555 | 000 |
| K051689 | 000 |
| K053241 | 000 |
| K060214 | 000 |
| K060217 | 000 |
| K060218 | 000 |
| K060493 | 000 |
| K070809 | 000 |
| K082538 | 000 |
| K082852 | 000 |
| K131331 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius