| Primary Device ID | 38169890200075 |
| NIH Device Record Key | 60a74ebe-ffb2-447f-9ec1-374627ddc3ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HK 2X Infiltration Tubing |
| Version Model Number | IT2X-10 |
| Catalog Number | IT2X-10 |
| Company DUNS | 106885259 |
| Company Name | HK SURGICAL INC. |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com | |
| Phone | 949-369-0101 |
| hkinfo@hksurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08169890200074 [Unit of Use] |
| GS1 | 10816989020079 [Unit of Use] |
| GS1 | 30816989020073 [Primary] |
| GS1 | 38169890200075 [Primary] |
| KGZ | Accessories, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-09-21 |
| 00816989021468 - HK Klein Infiltration Pump+ | 2025-10-07 HK Klein Infiltration Pump+ (KIP-II+) |
| 00816989021437 - HK Klein TDD Pump | 2024-09-06 HK Klein TDD Pump |
| 00816989021130 - HK Mercedes Cannula 3mm X 15cm Luer Lock | 2023-12-29 HK-2010-MER315LL (HK-2010 Mercedes Cannula 3mm X 15cm Luer Lock) |
| 00816989021147 - HK Mercedes Cannula 2mm X 15cm Luer Lock | 2023-12-29 HK-2010-MER215LL (HK-2010 Mercedes Cannula 2mm X 15cm Luer Lock) |
| 00816989021154 - HK Mercedes Cannula 3mm X 25cm Luer Lock | 2023-12-29 HK-2010-MER325LL (HK-2010 Mercedes Cannula 3mm X 25cm Luer Lock) |
| 00816989021161 - HK Mercedes Cannula 3mm X 30cm (12") Luer Lock | 2023-12-29 HK-2010-MER330LL (HK-2010 Mercedes Cannula 3mm X 30cm (12") Luer Lock) |
| 00816989021178 - HK Mercedes Cannula 4mm X 25cm Luer Lock | 2023-12-29 HK-2010-MER425LL (HK-2010 Mercedes Cannula 4mm X 25cm Luer Lock) |
| 00816989021185 - HK Mercedes Cannula 4mm X 30cm (12") Luer Lock | 2023-12-29 HK-2010-MER430LL (HK-2010 Mercedes Cannula 4mm X 30cm (12") Luer Lock) |