ARROW
- Primary DI
- 30801902111792
- Brand
- ARROW
- Company
- TELEFLEX INCORPORATED
- Model
- IPN036189
- Catalog number
- CDC-15123-P1A
- Device description
- Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Sharps Safety Features, and Maximal Barrier Precautions
- Published
- 2018-03-07
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| NIE | CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | Gastroenterology, Urology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 30801902111792 | Package | GS1 | 5 | Not in Commercial Distribution |
| 40801902111799 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 30801902111792 | 30801902111792 |
| 40801902111799 | 40801902111799 |
GMDN Terms
| Term | Definition |
|---|
| Haemodialysis/central venous catheterization kit | A collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access during haemodialysis, by: 1) conducting blood from a patient and returning it after extracorporeal circulation, primarily during haemodialysis, but may also be intended for haemoperfusion and/or apheresis; and 2) enabling central venous access for intravenous (IV) administration and/or invasive venous blood pressure monitoring. It includes a nonimplantable triple-lumen haemodialysis catheter, devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 20 Degrees Celsius | 25 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 002348191
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- true
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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|---|
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| 20801902202431 | ARROW | TELEFLEX INCORPORATED | NIE | 2024-09-06 |
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| 50884908133368 | TRIO-CT | Medical Components, Inc. | NIE | 2023-12-30 |
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