Navilyst Medical
GUDID H965PKM61057571S1
PICC Convenience Kit
NAVILYST MEDICAL, INC.
Peripherally-inserted central venous catheter| Primary Device ID | H965PKM61057571S1 |
| NIH Device Record Key | 202d67d1-d62d-4912-8812-4923c143a75f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navilyst Medical |
| Version Model Number | PKM61057571S |
| 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 | 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 | 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 |
Device Dimensions
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
| Length | 55 Centimeter |
| Catheter Gauge | 4 French |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 29 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H965PKM61057571S0 [Primary] |
| HIBCC | H965PKM61057571S1 [Package] Contains: H965PKM61057571S0 Package: BOX [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121990
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 | 2021-02-19 |
| Device Publish Date | 2018-08-29 |
On-Brand Devices [Navilyst Medical]
| H965PKM1404211S1 | Midline Convenience Kit |
| H96560M1303181 | Midline Convenience Kit |
| H96560M1303161 | Midline Convenience Kit |
| H965PKM140891S1 | Midline Convenience Kit |
| H965PKMR61072273S1 | Midline Convenience Kit |
| H965PKM61104301S1 | Midline Convenience Kit |
| H965PKM1635214S1 | Midline Convenience Kit |
| H965PKM61102511S1 | Midline Convenience Kit |
| H96560M0117651 | Midline Convenience Kit |
| H96560M011761 | Midline Convenience Kit |
| H96560M2110631 | Midline Convenience Kit |
| H965PKM1004112S1 | Midline Convenience Kit |
| H965PKM220853S1 | Midline Convenience Kit |
| H965PKM1220225S1 | Midline Convenience Kit |
| H965PKM220855S1 | Midline Convenience Kit |
| H965PKM231059S1 | Midline Convenience Kit |
| H965PKM220533S1 | Midline Convenience Kit |
| H965PKM011767S1 | Midline Convenience Kit |
| H96560M611095811 | Midline Convenience Kit |
| H96560M611052811 | Midline Convenience Kit |
| H965PKM1803411S1 | Midline Convenience Kit |
| H96560M610661411 | Midline Convenience Kit |
| H965PKM137985S1 | Midline Convenience Kit |
| H965PKM170031S1 | Midline Convenience Kit |
| H96560M611025111 | Midline Convenience Kit |
| H96560M610983611 | Midline Convenience Kit |
| H96560M610567631 | Midline Convenience Kit |
| H96560M610567621 | Midline Convenience Kit |
| H96560M2500981 | Midline Convenience Kit |
| H96560M2235211 | Midline Convenience Kit |
| H96560M2208541 | Midline Convenience Kit |
| H96560M2208531 | Midline Convenience Kit |
| H96560M2110621 | Midline Convenience Kit |
| H96560M18157131 | Midline Convenience Kit |
| H96560M18157101 | Midline Convenience Kit |
| H96560M1803430 | Midline Convenience Kit |
| H96560M1636031 | Midline Convenience Kit |
| H96560M1429481 | Midline Convenience Kit |
| H96560M1408911 | Midline Convenience Kit |
| H96560M1405661 | Midline Convenience Kit |
| H96560M1375411 | Midline Convenience Kit |
| H96560M1220291 | Midline Convenience Kit |
| H96560M1109131 | Midline Convenience Kit |
| H96560M1108511 | Midline Convenience Kit |
| H96560M0802011 | Midline Convenience Kit |
| H96560M05019131 | Midline Convenience Kit |
| H96560M05019121 | Midline Convenience Kit |
| H96560M0411541 | Midline Convenience Kit |
| H96560M0411531 | Midline Convenience Kit |
| H96560M0367081 | Midline Convenience Kit |
Trademark Results [Navilyst Medical]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NAVILYST MEDICAL 85054172 3907588 Live/Registered |
Navilyst Medical, Inc. 2010-06-03 |
 NAVILYST MEDICAL 77498811 3719467 Live/Registered |
NAVILYST MEDICAL, INC. 2008-06-13 |
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