ARROW
- Primary DI
- 20801902160236
- Brand
- ARROW
- Company
- TELEFLEX INCORPORATED
- Model
- IPN915217
- Catalog number
- SI-11142
- Device description
- MAC(TM) Two-Lumen Central Venous Access Set With Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters
- Published
- 2020-02-10
- 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
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20801902160236 | Package | GS1 | 5 | In Commercial Distribution |
| 10801902160239 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 20801902160236 | 20801902160236 |
| 10801902160239 | 10801902160239 |
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
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- 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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