FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD Phoenix™ NMIC/ID-121
DI: 30382904487219
·
Model: 448721
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- BD Phoenix™ NMIC/ID-121
- Primary DI
- 30382904487219
- Version / Model
- 448721
- Catalog Number
- 448721
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-08-09
- Public Version
- 5
- Public Version Date
- 2023-10-20
- Public Version Status
- Update
- Public Device Record Key
- 9532549b-8385-42a6-8df6-23685af28a81
- Distribution End Date
- 2019-07-18
Device Description
BD Phoenix™ NMIC/ID-121
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 | 30382904487219 | GS1 | ||||
| Unit of Use | 00382904487218 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020322 | 000 |
| K023444 | 000 |
| K023634 | 000 |
| K023858 | 000 |
| K024153 | 000 |
| K031429 | 000 |
| K031530 | 000 |
| K031699 | 000 |
| K031912 | 000 |
| K032153 | 000 |
| K032275 | 000 |
| K032299 | 000 |
| K032567 | 000 |
| K032655 | 000 |
| K033458 | 000 |
| K041384 | 000 |
| K042932 | 000 |
| K052269 | 000 |
| K060214 | 000 |
| K060217 | 000 |
| K060257 | 000 |
| K060444 | 000 |
| K060447 | 000 |
| K061327 | 000 |
| K061355 | 000 |
| K062944 | 000 |
| K062945 | 000 |
| K063301 | 000 |
| K063573 | 000 |
| K063811 | 000 |
| K063824 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius