| Primary Device ID | 50884908028800 |
| NIH Device Record Key | a750a013-cda5-4efa-86b1-224fbb465cb8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | MC217 |
| Company DUNS | 038000253 |
| Company Name | Medical Components, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884908028805 [Primary] |
| GS1 | 50884908028800 [Package] Contains: 00884908028805 Package: BOX [50 Units] In Commercial Distribution |
| DWS | Instruments, Surgical, Cardiovascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-11 |
| Device Publish Date | 2019-07-03 |
| 50884908093686 | FULL NURSING PICC PROCEDURE TRAY W/MAX BARRIER |
| 50884908090654 | FULL NURSING PICC PROCEDURE TRAY W/MAX BARRIER |
| 50884908056230 | ELYRIA MEMORIAL HOSPITAL (WITHOUT CATHETER) |
| 50884908055172 | BROOKLYN VETERANS ADMINISTRATION CUSTOM TRAY (WITHOUT CATHETER) |
| 50884908055035 | MCDLT TRAY (WITHOUT CATHETER) |
| 50884908054786 | CLEVELAND CLINIC CUSTOM TRAY (WITHOUT CATHETER) |
| 50884908054403 | CHRISTIANA CARE HOSPITAL SERVICES, INC. (WITH CHLORAPREP) (WITHOUT CATHETER) |
| 50884908054274 | UNIVERSAL CUSTOM TRAY (WITHOUT CATHETER) |
| 50884908054236 | ST. FRANCIS MEDICAL CENTER (WITHOUT CATHETER) |
| 50884908054168 | INSERTION TRAY (WITHOUT CATHETER) |
| 50884908054120 | TIMKEN MERCY HOSPITAL (WITHOUT CATHETER) |
| 50884908054113 | YORK HOSPITAL (WITHOUT CATHETER) |
| 50884908054038 | ROBERT WOOD JOHNSON UNIVERSITY CUSTOM TRAY (WITHOUT CATHETER) |
| 50884908053949 | RIVERSIDE REGIONAL MEDICAL CENTER UNIVERSAL CUSTOM TRAY (WITHOUT CATHETER) |
| 50884908053925 | LUTHERAN GENERAL HOSPITAL (WITHOUT CATHETER) |
| 50884908028800 | 21GA (0.80MM OD; 0.60MM ID) X 7CM ECHO TIP NEEDLE |
| 50884908028053 | U IOWA CUSTOM TRAY |
| 50884908027025 | ACUTE HEMODIALYSIS TRAY (WITHOUT CATHETER) |
| 00884908026771 | UNIVERSAL SELDINGER INTRO KIT (WITHOUT CATHETER) |
| 50884908097134 | INTRODUCER KIT FOR HEMO-FLOW (ISRAEL) |
| 50884908093341 | 5.5F (1.9MM ID) X 10CM TEARAWAY INTRODUCER ACCESSORY KIT |
| 50884908088415 | 7F (2.3MM ID) X 15CM TEARAWAY INTRODUCER SET |
| 50884908033859 | 0.035" (0.90MM) X 150CM BENTSON PTFE COATED GUIDEWIRE W/FLOPPY TIP |
| 50884908033712 | 5.5F (1.9MM ID) X 10CM TEARAWAY INTRODUCER SET W/NITINOL GUIDEWIRE W/RADIOPAQUE TIP |
| 50884908033545 | ACCESSORY PACK GOWN/DRAPE/CAP/MASK |
| 50884908033538 | MAXIMUM BARRIER PROTECTION TRAY |
| 50884908003159 | PICC ACCESSORY PACK ARROWHEAD |
| 50884908143657 | 21GA (0.85MM OD;0.60MM ID) X 7CM SAFETY NEEDLE W/ECHO TIP |
| 50884908143633 | 21GA (0.80MM OD;0.60MM ID) X 7CM ECHO TIP NEEDLE |
| 50884908143626 | 21GA (0.85MM OD;0.60MM ID) X 5CM SAFETY NEEDLE W/ECHO TIP |
| 50884908115173 | 1- BARBED TUNNELER FOR 6F PRO-LINE® |
| 50884908115166 | 1 - 0.054" BARBED TUNNELER FOR 5F PRO-LINE® |
| 50884908095758 | 0.042" BARBED TUNNELER FOR 4F VASCU-LINE® |
| 50884908028862 | 15.5F HEMO-FLOW®/15.5F TITAN TUNNELER |
| 50884908028824 | 21GA (0.85MM OD;0.60MM ID) X 7CM SAFETY NEEDLE W/ECHO TIP |
| 50884908028794 | 21GA (0.85MM OD;0.60MM ID) X 5 CM SAFETY NEEDLE W/ECHO TIP |
| 50884908026837 | STATLOCK® SECUREMENT SYSTEM |
| 30884908146043 | REPAIR KIT |
| 50884908145996 | 5.5F (1.9MM ID) X 10CM TEARAWAY INTRODUCER ACCESSORY KIT |
| 50884908145972 | 7F (2.3MM ID) X 15CM TEARAWAY INTRODUCER SET |
| 50884908145101 | 0.010" (0.27MM) X 60CM STAINLESS STEEL GUIDEWIRE W/HYDROPHILIC COATING |
| 30884908145084 | 0.010" (0.27MM) X 80CM STAINLESS STEEL GUIDEWIRE WITH HYDROPHILIC COATING |
| 50884908150259 | 14F X 90CM DOUBLE LUMEN LT CVC BASIC KIT |
| 50884908150242 | 9.5F X 90CM DUAL LUMEN LT CVC BASIC KIT |
| 50884908146214 | VEIN PICK |
| 50884908145231 | 18GA (1.3MM OD;1.0MM ID) X 7CM INTRODUCER NEEDLE |
| 50884908144746 | TUNNELING ROD |
| 50884908144722 | RAULERSON RING HANDLED TUNNELER |
| 50884908144715 | TUNNELING STYLET |
| 50884908144708 | 0.074" BARBED TUNNELER FOR 7F PRO-LINE® |