Vaxcel
GUDID M001459841
Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 5F x 10cm Catheter, and Radiopaque Tip
NAVILYST MEDICAL, INC.
Vascular catheter introduction set, nonimplantable| Primary Device ID | M001459841 |
| NIH Device Record Key | c9dfcd1e-1627-4894-9451-63f28f612b1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vaxcel |
| Version Model Number | 45984 |
| Company DUNS | 809699023 |
| Company Name | NAVILYST MEDICAL, 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com |
Device Dimensions
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Needle Gauge | 21 Gauge |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
| Outer Diameter | 1.8 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Catheter Gauge | 5 French |
| Length | 10 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M001459840 [Primary] |
| HIBCC | M001459841 [Package] Contains: M001459840 Package: BOX [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K974640
FDA Product Code
| DRE | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
| LDF | ELECTRODE, PACEMAKER, TEMPORARY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2015-09-15 |
On-Brand Devices [Vaxcel]
| M001459941 | Vaxcel Mini Stick Kit Coaxial Dialtor Set |
| M001459931 | Vaxcel Mini Stick Kit Coaxial Dialtor Set |
| M001459921 | Vaxcel Mini Stick Kit Coaxial Dialtor Set |
| M001459911 | Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 6F x 10cm Catheter, NiTi Guidewire, a |
| M001459901 | Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 5F x 10cm Catheter, NiTi Guidewire, a |
| M001459891 | Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 4.5F x 10cm Catheter, NiTi Guidewire, |
| M001459881 | Vaxcel Mini Stick Kit Coaxial Dialtor Set |
| M001459871 | Vaxcel Mini Stick Kit Coaxial Dialtor Set |
| M001459861 | Vaxcel Mini Stick Kit Coaxial Dialtor Set |
| M001459851 | Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 6F x 10cm Catheter, and Radiopaque Ti |
| M001459841 | Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 5F x 10cm Catheter, and Radiopaque Ti |
| M001459821 | Vaxcel Mini Stick Kit Coaxial Dialtor Set |
| M001459811 | Vaxcel Mini Stick Kit Coaxial Dialtor Set |
| M001459801 | Vaxcel Mini Stick Kit Coaxial Dialtor Set |
| H96560M0800421 | PICC Convenience Kit |
| H96560M0800411 | PICC Convenience Kit |
| H96560M0307031 | PICC Convenience Kit |
| H96560M0307021 | PICC Convenience Kit |
| H96560M0307011 | PICC Convenience Kit |
| H96560M0169621 | PICC Convenience Kit |
| H965454370 | Vaxcel PICC with PASV Valve - 3F x 60cm Polyurethane Catheter Intermediate MST Kit |
| H965454360 | Vaxcel PICC with PASV Valve - 3F x 60cm Polyurethane Catheter MST-60 Kit |
| H965454350 | Vaxcel PICC with PASV Valve - 3F x 60cm Polyurethane Catheter Kit |
| M001455980 | Vaxcel PICC with PASV Valve - 5F x 60cm Polyurethane Catheter Intermediate MST Kit |
| M001455940 | Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter Intermediate MST Kit |
| M001454790 | Vaxcel PICC with PASV Valve - 6F x 60cm Dual Lumen Polyurethane Catheter MST-60 Kit |
| M001454780 | Vaxcel PICC with PASV Valve - 6F x 60cm Dual Lumen Polyurethane Catheter IR-145 Kit |
| M001454770 | Vaxcel PICC with PASV Valve - 6F x 60cm Dual Lumen Polyurethane Catheter MST-30 Kit |
| M001454740 | Vaxcel PICC with PASV Valve - 5F x 60cm Dual Lumen Polyurethane Catheter MST-60 Kit |
| M001454730 | Vaxcel PICC with PASV Valve - 5F x 60cm Dual Lumen Polyurethane Catheter IR-145 Kit |
| M001454710 | Vaxcel PICC with PASV Valve - 5F x 60cm Dual Lumen Polyurethane Catheter Introducer Kit |
| M001454700 | Vaxcel PICC with PASV Valve - 5F x 60cm Polyurethane Catheter Kit |
| M001454640 | Vaxcel PICC with PASV Valve - 5F x 60cm Polyurethane Catheter MST-60 Kit |
| M001454630 | Vaxcel PICC with PASV Valve - 5F x 60cm Polyurethane Catheter IR-145 Kit |
| M001454620 | Vaxcel PICC with PASV Valve - 5F x 60cm Polyurethane Catheter MST-30 Kit |
| M001454610 | Vaxcel PICC with PASV Valve - 5F x 60cm Polyurethane Catheter Introducer Kit |
| M001454580 | Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter IR-145 Kit |
| M001454570 | Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter MST-30 Kit |
| M001454560 | Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter Introducer Kit |
| M001454550 | Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter Kit |
| M001454720 | Vaxcel PICC with PASV Valve - 5F x 60cm Dual Lumen Polyurethane Catheter MST-30 Kit |
| M001454590 | Vaxcel PICC with PASV Valve - 4F x 60cm Polyurethane Catheter MST-60 Kit |
| M001455840 | 9in Vaxcel Plus Chronic Dialysis Catheter Plastic Tunneler |
| M001455830 | 9in Vaxcel Plus Chronic Dialysis Catheter Metal Tunneler |
| M001455590 | 14.5F x 50cm Vaxcel Plus Chronic Dialysis Catheter with Plastic Tunneler and 3 Introducer Needle |
| M001455580 | 14.5F x 50cm Vaxcel Plus Chronic Dialysis Catheter with Metal Tunneler and 3 Introducer Needle S |
| M001455570 | 14.5F x 50cm Vaxcel Plus Chronic Dialysis Catheter with Plastic Tunneler |
| M001455560 | 14.5F x 50cm Vaxcel Plus Chronic Dialysis Catheter with Metal Tunneler |
| M001455550 | 14.5F x 37cm Vaxcel Plus Chronic Dialysis Catheter with Plastic Tunneler and 3 Introducer Needle |
| M001455540 | 14.5F x 37cm Vaxcel Plus Chronic Dialysis Catheter with Metal Tunneler and 3 Introducer Needle S |
Trademark Results [Vaxcel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VAXCEL 86303096 4671164 Live/Registered |
VAXCEL INTERNATIONAL CO., LTD. 2014-06-06 |
 VAXCEL 78387758 3319458 Live/Registered |
NAVILYST MEDICAL, INC. 2004-03-19 |
 VAXCEL 75592102 2669464 Live/Registered |
NAVILYST MEDICAL, INC. 1998-08-20 |
 VAXCEL 74358461 not registered Dead/Abandoned |
VAXCEL, INC. 1993-02-12 |
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