| Primary Device ID | 50884908098087 |
| NIH Device Record Key | 0fead713-67e4-45e1-b318-37523bf0be81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 400XL |
| Version Model Number | DFXL146CES |
| Company DUNS | 038000253 |
| Company Name | Medical Components, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | +1(215)256-4201 |
| clinical@medcompnet.com | |
| Phone | +1(215)256-4201 |
| clinical@medcompnet.com | |
| Phone | +1(215)256-4201 |
| clinical@medcompnet.com | |
| Phone | +1(215)256-4201 |
| clinical@medcompnet.com | |
| Phone | +1(215)256-4201 |
| clinical@medcompnet.com | |
| Phone | +1(215)256-4201 |
| clinical@medcompnet.com | |
| Phone | +1(215)256-4201 |
| clinical@medcompnet.com | |
| Phone | +1(215)256-4201 |
| clinical@medcompnet.com | |
| Phone | +1(215)256-4201 |
| clinical@medcompnet.com | |
| Phone | +1(215)256-4201 |
| clinical@medcompnet.com | |
| Phone | +1(215)256-4201 |
| clinical@medcompnet.com | |
| Phone | +1(215)256-4201 |
| clinical@medcompnet.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884908098082 [Primary] |
| GS1 | 50884908098087 [Package] Contains: 00884908098082 Package: box [5 Units] In Commercial Distribution |
| MPB | CATHETER, HEMODIALYSIS, NON-IMPLANTED |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-10-22 |
| 50884908126148 | 14F X 12CM 400XL IJ CATHETER SET |
| 50884908098728 | 14F X 24CM 400XL W/CURVED EXTENSIONS CATHETER SET |
| 50884908098674 | 14F X 20CM 400XL W/CURVED EXTENSIONS CATHETER SET |
| 50884908098629 | 14F X 15CM 400XL W/CURVED EXTENSIONS CATHETER SET |
| 50884908098575 | 14F X 12CM 400XL W/CURVED EXTENSIONS CATHETER SET |
| 50884908098513 | 14F X 24CM 400XL W/CURVED EXTENSIONS MAX BARRIER |
| 50884908098452 | 14F X 20CM 400XL W/CURVED EXTENSIONS MAX BARRIER |
| 50884908098407 | 14F X 15CM 400XL W/CURVED EXTENSIONS MAX BARRIER |
| 50884908098353 | 14F X 24CM 400XL W/CURVED EXTENSIONS FULL TRAY |
| 50884908098308 | 14F X 20CM 400XL W/CURVED EXTENSIONS FULL TRAY |
| 50884908098254 | 14F X 15CM 400XL W/CURVED EXTENSIONS FULL TRAY |
| 50884908098209 | 14F X 24CM 400XL W/CURVED EXTENSIONS BASIC SET |
| 50884908098155 | 14F X 20CM 400XL W/CURVED EXTENSIONS BASIC SET |
| 50884908098087 | 14F X 15CM 400XL W/CURVED EXTENSIONS BASIC SET |
| 50884908098032 | 14F X 24CM 400XL W/CURVED EXTENSIONS CATHETER ONLY |
| 50884908097943 | 14F X 15CM 400XL W/CURVED EXTENSIONS CATHETER ONLY |
| 50884908095390 | 14F X 24CM 400XL IJ MAX BARRIER TRAY |
| 50884908095383 | 14F X 24CM 400XL STRAIGHT CATHETER MAX BARRIER |
| 50884908095376 | 14F X 20CM 400XL IJ MAX BARRIER TRAY |
| 50884908095369 | 14F X 20CM 400XL STRAIGHT CATHETER MAX BARRIER |
| 50884908095352 | 14F X 15CM 400XL IJ MAX BARRIER TRAY |
| 50884908095345 | 14F X 15CM 400XL STRAIGHT CATHETER MAX BARRIER |
| 50884908039196 | 14F X 20CM 400XL IJ FULL SET |
| 50884908039189 | 14F X 15CM 400XL IJ FULL SET |
| 50884908039172 | 14F X 12CM 400XL IJ FULL SET |
| 50884908039165 | 14F X 24CM 400XL STRAIGHT FULL SET |
| 50884908039158 | 14F X 20CM 400XL STRAIGHT FULL SET |
| 50884908039110 | 14F X 20CM 400XL IJ (CATHETER ONLY) |
| 50884908039073 | 14F X 20CM 400XL STRAIGHT (CATHETER ONLY) |
| 50884908039066 | 14F X 15CM 400XL STRAIGHT (CATHETER ONLY) |
| 50884908037765 | 11.5F X 20CM DUO-FLOW® IJ FULL SET |
| 50884908027902 | 8F X 20CM SUBCLAVIAN CATHETER WITH REMOVABLE "Y" ADAPTOR |
| 50884908027889 | 8F X 15CM SUBCLAVIAN CATHETER WITH REMOVABLE "Y" ADAPTOR |
| 50884908026325 | 11.5F X 20CM DUO-FLOW® IJ W/ 2 SUTURE WINGS FULL TRAY |
| 50884908009380 | 14F X 24CM 400XL |
| 50884908009335 | 14F X 24CM 400XL CATHETER SET |
| 50884908009298 | 14F X 24CM 400XL IJ CATHETER SET |
| 50884908009274 | 14F X 24CM 400XL IJ CATHETER |
| 50884908009267 | 14F X 24CM 400XL IJ CATHETER KIT |
| 50884908009250 | 14F X 24CM 400XL CATHETER |
| 50884908009243 | 14F X 24CM 400XL TRAY |
| 50884908009236 | 14F X 20CM 400XL |
| 50884908009182 | 14F X 20CM 400XL CATHETER SET |
| 50884908009137 | 14F X 20CM 400XL IJ CATHETER SET |
| 50884908009120 | 14F X 24CM 400XL IJ CATHETER WITH SUTURE WING |
| 50884908009113 | 14F X 20CM 400XL IJ CATHETER TRAY |
| 50884908009106 | 14F X 20CM 400XL IJ CATHETER KIT |
| 50884908009090 | 14F X 20CM 400XL CATHETER |
| 50884908009083 | 14F X 20CM 400XL TRAY |
| 50884908009076 | 14F X 15CM 400XL |