| Primary Device ID | 50884908039851 |
| NIH Device Record Key | 381704f8-c083-41c3-b3f4-1eb8fb3f59bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REPAIR KIT |
| Version Model Number | RPK-01 |
| 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 |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884908039856 [Primary] |
| GS1 | 50884908039851 [Package] Contains: 00884908039856 Package: box [5 Units] In Commercial Distribution |
| NFK | Kit, repair, catheter, hemodialysis |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2015-10-23 |
| 30884908146562 - BREEZE® BILIARY DRAINAGE CATHETER | 2025-12-29 8F X 40CM BREEZE® BILIARY DRAIN WITH LOCKING PIGTAIL SET |
| 30884908146579 - BREEZE® BILIARY DRAINAGE CATHETER | 2025-12-29 10F X 40CM BREEZE® BILIARY DRAIN WITH LOCKING PIGTAIL SET |
| 30884908146586 - BREEZE® BILIARY DRAINAGE CATHETER | 2025-12-29 12F X 40CM BREEZE® BILIARY DRAIN WITH LOCKING PIGTAIL SET |
| 30884908146593 - BREEZE® BILIARY DRAINAGE CATHETER | 2025-12-29 14F X 40CM BREEZE® BILIARY DRAIN WITH LOCKING PIGTAIL SET |
| 30884908148009 - BREEZE® BILIARY DRAINAGE CATHETER | 2025-12-29 8F X 40CM BREEZE® BILIARY DRAIN WITHOUT LOCKING PIGTAIL SET |
| 30884908148023 - BREEZE® BILIARY DRAINAGE CATHETER | 2025-12-29 10F X 40CM BREEZE® BILIARY DRAIN WITHOUT LOCKING PIGTAIL SET |
| 30884908148047 - BREEZE® BILIARY DRAINAGE CATHETER | 2025-12-29 12F X 40CM BREEZE® BILIARY DRAIN WITHOUT LOCKING PIGTAIL SET |
| 30884908148061 - BREEZE® BILIARY DRAINAGE CATHETER | 2025-12-29 14F X 40CM BREEZE® BILIARY DRAIN WITHOUT LOCKING PIGTAIL SET |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() REPAIR KIT 76659832 3851782 Live/Registered |
SKYLINE ENCAP HOLDINGS, LLC 2006-05-10 |