FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Intelliport
DI: 00382905167041
·
Model: 516704
·
BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BD Intelliport
- Primary DI
- 00382905167041
- Version / Model
- 516704
- Catalog Number
- 516704
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-30
- Public Version
- 1
- Public Version Date
- 2020-10-08
- Public Version Status
- New
- Public Device Record Key
- c079b376-bd68-4279-8617-f27fb4813201
Device Description
KIT TABLET
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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 65031 | Intravenous injection automated detection/documentation system computer | An electronic component of an intravenous (IV) injection automated detection/documentation system, intended to electronically receive IV bolus injection data (time, drug, dosage) from the system processor/transmitter and document the data [e.g., within the electronic health record (EHR)] as part of automatic detection/documentation of patient anaesthesia dosing. It includes a monitor and keyboard (e.g., in the form of a touchscreen tablet) with wireless connectivity, and dedicated system software. Data that is documented includes drug name, volume, and concentration (dose), and time of dose administration. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382905167041 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature