FDA UDI
In Commercial Distribution
🇺🇸 United States
TRIO-CT®
DI: 00884908182620
·
Model: ANG01135240
·
Medical Components, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- TRIO-CT®
- Primary DI
- 00884908182620
- Version / Model
- ANG01135240
- Catalog Number
- ANG01135240
- Company Name
- Medical Components, Inc.
- Labeler DUNS
- 038000253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-05
- Public Version
- 1
- Public Version Date
- 2025-03-13
- Public Version Status
- New
- Public Device Record Key
- e8de0cd4-494e-45e8-9d38-28fe13c25cd3
Device Description
13.5F X 24CM TRIO-CT® TRIPLE LUMEN CATHETER CATHETER ONLY
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| NIE | Catheter, hemodialysis, triple lumen, non-implanted | Gastroenterology, Urology | 876.5540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61629 | Triple-lumen haemodialysis catheter | A sterile, flexible, triple-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access to: 1) conduct blood from a patient and return it after extracorporeal circulation, primarily during haemodialysis, but may also be intended for haemoperfusion and/or apheresis; and 2) enable central venous access for intravenous (IV) administration and/or invasive venous blood pressure monitoring. It includes three lumens, two dedicated to coaxial flow of blood for dialysis, and the third intended for independent IV access. Devices dedicated to catheter introduction/function may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50884908182625 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 00884908182620 | GS1 |
Customer Contacts
- Phone
- +1(215)256-4201
- [email protected]