FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDRAD® Centargo Patient Line
DI: 09345390003530
·
Model: CENT-PL
·
IMAXEON PTY LTD
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MEDRAD® Centargo Patient Line
- Primary DI
- 09345390003530
- Version / Model
- CENT-PL
- Catalog Number
- CENT-PL
- Company Name
- IMAXEON PTY LTD
- Labeler DUNS
- 740733993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-10
- Public Version
- 1
- Public Version Date
- 2025-12-18
- Public Version Status
- New
- Public Device Record Key
- cf163f98-83c4-4a8f-b391-4567eb6fa468
- Distribution End Date
- 9999-12-31
Device Description
ASSY,TUBESET,CENTARGO SUDS,US (91855938)
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | Cardiovascular | 870.1650 | 2 |
| IZQ | Injector, Contrast Medium, Automatic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44685 | Radiographic procedure tubing | A flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 49345390003538 | GS1 | Box | 50 | In Commercial Distribution | 9999-12-31 |
| Primary | 09345390003530 | GS1 |
Customer Contacts
- Phone
- +1 800-633-7231
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius