Vaxcel
GUDID H96560M0800411
PICC Convenience Kit
NAVILYST MEDICAL, INC.
Peripherally-inserted central venous catheter| Primary Device ID | H96560M0800411 |
| NIH Device Record Key | b74242ad-7276-41f3-a2d4-457d2c7b66db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vaxcel |
| Version Model Number | 60M080041 |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H96560M0800410 [Primary] |
| HIBCC | H96560M0800411 [Package] Contains: H96560M0800410 Package: BOX [3 Units] In Commercial Distribution |
FDA Product Code
| LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-09-17 |
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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