FDA UDI
In Commercial Distribution
🇺🇸 United States
PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST) (SINGLE/DOUBLE 5F-6FX60CM
DI: 00884908160376
·
Model: MD28036101
·
Medical Components, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST) (SINGLE/DOUBLE 5F-6FX60CM
- Primary DI
- 00884908160376
- Version / Model
- MD28036101
- Catalog Number
- MD28036101
- Company Name
- Medical Components, Inc.
- Labeler DUNS
- 038000253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-15
- Public Version
- 1
- Public Version Date
- 2026-01-23
- Public Version Status
- New
- Public Device Record Key
- 9e59f181-5543-4760-8295-c5ffe79c62b5
Device Description
6F X 60CM SINGLE LUMEN PRO-LINE® CT BASIC IR SET
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 |
|---|---|---|---|---|
| LJS | Catheter, intravascular, therapeutic, long-term greater than 30 days | General Hospital | 880.5970 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10729 | Centrally-inserted central venous catheter | A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50884908160371 | GS1 | box | 5 | In Commercial Distribution | |
| Primary | 00884908160376 | GS1 |
Customer Contacts
- Phone
- +1(215)256-4201
- [email protected]