FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Tri-Flow
DI: 00884908060331
·
Model: XTP3114CTPC
·
Medical Components, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Tri-Flow
- Primary DI
- 00884908060331
- Version / Model
- XTP3114CTPC
- Company Name
- Medical Components, Inc.
- Labeler DUNS
- 038000253
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-23
- Public Version
- 6
- Public Version Date
- 2022-05-12
- Public Version Status
- Update
- Public Device Record Key
- f8eefdbf-3f03-4e14-af63-6bb35e900bd6
- Distribution End Date
- 2022-04-28
Device Description
11.5F X 12CM Tri-Flow IJ 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
- 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
- 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 |
|---|---|---|---|---|
| FOZ | Catheter,intravascular,therapeutic,short-term less than 30 days | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46979 | Double-lumen haemodialysis catheter, nonimplantable | A flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) 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 | 50884908060336 | GS1 | box | 10 | Not in Commercial Distribution | 2022-04-28 |
| Primary | 00884908060331 | GS1 |
Customer Contacts
- Phone
- +1(215)256-4201
- [email protected]