FDA UDI
In Commercial Distribution
🇺🇸 United States
BD PhoenixSpec™ Nephelometer
DI: 00382904409104
·
Model: 440910
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD PhoenixSpec™ Nephelometer
- Primary DI
- 00382904409104
- Version / Model
- 440910
- Catalog Number
- 440910
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 122561087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-25
- Public Version
- 1
- Public Version Date
- 2018-06-25
- Public Version Status
- New
- Public Device Record Key
- c271fa07-285a-4091-851d-9a5c8ebc5511
Device Description
BD PhoenixSpec™ Nephelometer
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JQX | NEPHELOMETER, FOR CLINICAL USE | Clinical Chemistry | 862.2700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57870 | Microorganism-density nephelometer IVD | A mains electricity (AC-powered) laboratory instrument intended to be used to determine the density of microorganism suspensions by comparing the turbidity of a solution with that of McFarland standards using a photometric detection system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382904409104 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 7.87 | Inch | |
| Length | 13.62 | Inch | |
| Height | 5.75 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius