FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BD Intelliport
DI: 00382905167003
·
Model: 516700
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BD Intelliport
- Primary DI
- 00382905167003
- Version / Model
- 516700
- Catalog Number
- 516700
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-30
- Public Version
- 6
- Public Version Date
- 2026-04-28
- Public Version Status
- Update
- Public Device Record Key
- 7ffdf43e-978e-4b2b-9902-943b8730fe3e
- Distribution End Date
- 2025-03-21
Device Description
SENSOR
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
- Yes
- MRI Safety
- MR Unsafe
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PHC | Infusion safety management software | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65029 | Intravenous line sensor, anaesthesia injection | A noninvasive electronic component of an intravenous (IV) injection automated detection/documentation system, intended to be connected between an IV line and a medication syringe to measure the volume of anaesthesia medication administered as bolus injection to the patient, for subsequent patient dosing documentation. It includes an electronic sensor to a lumen/fluid path, Luer connectors at each end, and is intended to electronically interface with the system processor (not included), which collects and processes the raw sensory data. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382905167003 | GS1 | ||||
| Package | 50382905167008 | GS1 | Case | 50 | Not in Commercial Distribution | 2025-03-21 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 29 Degrees Celsius