ARROW
- Primary DI
- 20801902129516
- Brand
- ARROW
- Company
- TELEFLEX INCORPORATED
- Model
- IPN037590
- Catalog number
- ASK-12123-OFH
- Device description
- Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions
- Published
- 2016-11-11
- Public version status
- Update
- 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 |
|---|
| 20801902129516 | Package | GS1 | 5 | Not in Commercial Distribution |
| 10801902129519 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 20801902129516 | 20801902129516 |
| 10801902129519 | 10801902129519 |
GMDN Terms
| Term | Definition |
|---|
| Vascular catheter introduction set, nonimplantable | A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. |
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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| 50884908133344 | TRIO-CT | Medical Components, Inc. | NIE | 2023-12-30 |
| 50884908133351 | TRIO-CT | Medical Components, Inc. | NIE | 2023-12-30 |
| 50884908133368 | TRIO-CT | Medical Components, Inc. | NIE | 2023-12-30 |
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