FDA UDI
In Commercial Distribution
🇺🇸 United States
BD Intelliport System
DI: 00382905168031
·
Model: 516803
·
BECTON, DICKINSON AND COMPANY
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- BD Intelliport System
- Primary DI
- 00382905168031
- Version / Model
- 516803
- Catalog Number
- 516803
- Company Name
- BECTON, DICKINSON AND COMPANY
- Labeler DUNS
- 001292192
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-07
- Public Version
- 1
- Public Version Date
- 2024-06-17
- Public Version Status
- New
- Public Device Record Key
- 1c8fc60f-cf94-4560-bdc2-16c7083b3263
Device Description
SYRINGE LABELER INK CARTRIDGE
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
- Yes
- 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 |
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65030 | Intravenous injection automated detection/documentation system processor/transmitter | A noninvasive electronic component of an intravenous (IV) injection automated detection/documentation system, intended to electronically interface with a system sensor to: 1) provide power to, and extract IV bolus injection volume data from, the sensor; and 2) process and wirelessly transmit data to a computer as part of automatic detection/documentation of patient anaesthesia dosing. It is typically designed as a sensor base with a processor and wireless transmitter; it might include a barcode reader (for encoded syringe scanning) and an internal clock (for time of dose data collection). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60382905168033 | GS1 | Carton | 24 | In Commercial Distribution | |
| Primary | 00382905168031 | GS1 | ||||
| Package | 50382905168036 | GS1 | Case | 4 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius