| Primary Device ID | 30849884007177 | 
| NIH Device Record Key | f0265650-fe39-42a0-b4f6-4d559a5f1260 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | VYGON | 
| Version Model Number | AMS-9034CS | 
| Catalog Number | AMS-9034CS | 
| Company DUNS | 120818216 | 
| Company Name | Vygon Corporation | 
| 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 | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00849884007176 [Primary] | 
| GS1 | 30849884007177 [Package] Contains: 00849884007176 Package: [20 Units] In Commercial Distribution | 
| LRS | I.V. start kit | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-08-22 | 
| Device Publish Date | 2025-08-14 | 
| 38498840011929 | MARKED NITI/AU GUIDEWIRE, 0/018" X 130CM | 
| 38498840011905 | MARKED NITINOL GUIDEWIRE, 0.018" X 80CM | 
| 38498840012216 | 3.5F X 5CM PTFE TEARAWAY INTRODUCER | 
| 38498840011912 | STAINLESS STEEL GUIDEWIRE, 0.018" X 80CM | 
| 38498840011899 | NITI/AU GUIDEWIRE, 0.018" X 70CM | 
| 38498840011882 | NITI/SS GUIDEWIRE, 0.018" X 45CM | 
| 38498840011875 | MARKED NITI/AU GUIDEWIRE, 0.018" X 45CM | 
| 38498840011813 | 5.5F X 10CM PTFE TEARAWAY INTRODUCER | 
| 38498840011806 | 4.5F X 10CM PTFE TEARAWAY INTRODUCER | 
| 38498840011790 | 6F X 7CM PTFE TEARAWAY INTRODUCER | 
| 38498840011783 | 5.5F X 7CM PTFE TEARAWAY INTRODUCER | 
| 38498840011776 | 4.0F X 7CM PTFE TEARAWAY INTRODUCER | 
| 38498840011769 | 21GA. X 7CM INTRODUCER NEEDLE | 
| 38498840011752 | 21GA. X 4CM INTRODUCER NEEDLE | 
| 38498840011318 | 21GA SAFETY NEEDLE, 7CM | 
| 38498840011301 | 21GA SAFETY NEEDLE, 4CM | 
| 38498840012568 | ULTRASOUND IV START KIT | 
| 38498840012230 | 4" MICROBORE EXTENSION SET | 
| 38498840012223 | 3.5FR MST INSERTION KIT | 
| 38498840012193 | CENTRAL LINE DRESSING KIT | 
| 38498840011844 | 6.0FR MST INSERTION KIT | 
| 38498840011837 | 5.5FR MST INSERTION KIT | 
| 38498840011820 | 4.0FR MST INSERTION KIT | 
| 38498840012537 | PREP KIT | 
| 38498840012391 | PROCEDURE KIT | 
| 38498840012384 | PICC INSERTION TRAY | 
| 38498840012360 | VAD KIT W/ CHLORAPREP | 
| 38498840012353 | VAD ACCESS KIT | 
| 38498840012308 | VAD ACCESS KIT | 
| 38498840012278 | VAD ACCESS TRAY | 
| 38498840012254 | LEADERFLEX INSERTION KIT | 
| 38498840011936 | PREP KIT | 
| 38498840011677 | PROCEDURE TRAY | 
| 38498840011646 | PIV INSERTION KIT | 
| 38498840011363 | CENTRAL LINE KIT | 
| 38498840011226 | CENTRAL VENOUS CATHETER KIT | 
| 38498840011042 | PICC INSERTION TRAY | 
| 38498840011035 | LEADERFLEX INSERTION KIT | 
| 38498840010830 | LEADERFLEX INSERTION KIT | 
| 38498840010663 | CENTRAL LINE KIT | 
| 38498840010649 | PICC INSERTION TRAY | 
| 38498840010632 | PICC INSERTION TRAY | 
| 38498840010564 | NEONATAL PICC TRAY | 
| 38498840010502 | CENTRAL LINE KIT | 
| 38498840010496 | PICC/MIDLINE KIT | 
| 38498840010151 | LEADERFLEX INSERTION TRAY | 
| 38498840010144 | PICC LINE TRAY | 
| 38498840010076 | INSERTION TRAY | 
| 38498840010069 | MAXIMUM BARRIER TRAY | 
| 38498840010007 | PICC INSERTION TRAY | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  VYGON  85083411  4021503 Live/Registered | VYGON 2010-07-13 | 
|  VYGON  79340347  not registered Live/Pending | VYGON 2022-03-29 | 
|  VYGON  79019449  3211611 Live/Registered | VYGON 2005-11-14 | 
|  VYGON  76383231  2763518 Dead/Cancelled | Vygon 2002-03-12 |