FDA UDI
In Commercial Distribution
🇺🇸 United States
BD MicroProbe™ Processor
DI: 00382902501008
·
Model: 250100
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD MicroProbe™ Processor
- Primary DI
- 00382902501008
- Version / Model
- 250100
- Catalog Number
- 250100
- 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
- 4
- Public Version Date
- 2023-11-16
- Public Version Status
- Update
- Public Device Record Key
- a3615135-fe6c-4fca-a723-2d8c77e12af8
Device Description
BD MicroProbe™ Processor (120 V)
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| JQW | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE | Clinical Chemistry | 862.2750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48030 | Isothermal nucleic acid amplification analyser IVD, laboratory | An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen at a constant (isothermal) temperature, using a series of transcription and reverse transcription reactions, and to detect and/or identify the amplified product using oligonucleotide markers as it is produced (e.g., in real-time). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382902501008 | GS1 |
Customer Contacts
- Phone
- +1(800)638-8663
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K923268 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 16 | Centimeter | |
| Width | 26 | Centimeter | |
| Depth | 24 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 22 – 28 Degrees Celsius