Xcela
GUDID H965PKM61055312S1
PICC Convenience Kit
NAVILYST MEDICAL, INC.
Peripherally-inserted central venous catheter| Primary Device ID | H965PKM61055312S1 |
| NIH Device Record Key | 61a85227-2e53-4be2-9904-c1c93335799e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Xcela |
| Version Model Number | PKM61055312S |
| 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 |
Device Dimensions
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
| Length | 55 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 5 French |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H965PKM61055312S0 [Primary] |
| HIBCC | H965PKM61055312S1 [Package] Contains: H965PKM61055312S0 Package: BOX [3 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 | 2018-12-18 |
On-Brand Devices [Xcela]
| H965PKM61095323S1 | PICC Convenience Kit |
| H96560M2120821 | PICC Convenience Kit |
| H965750710 | Xcela Power Injectable PICC (6F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nu |
| H965750700 | Xcela Power Injectable PICC (5F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nu |
| H965750690 | Xcela Power Injectable PICC (5F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape |
| H965750680 | Xcela Power Injectable PICC (4F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape |
| H965440430 | Xcela Plus Titanium Port with PASV Valve Technology (Non-Filled Suture Holes) and 8F x 63cm Poly |
| H965440410 | Xcela Plus Titanium Port with PASV Valve Technology (Non-Filled Suture Holes) and 6F x 63cm Poly |
| H965440400 | Xcela Plus Plastic Port with PASV Valve Technology (Filled Suture Holes) and 8F x 63cm Polyureth |
| H965440390 | Xcela Plus Plastic Port with PASV Valve Technology (Non-Filled Suture Holes) and 8F x 63cm Polyu |
| H965440380 | Xcela Plus Plastic Port with PASV Valve Technology (Filled Suture Holes) and 6F x 63cm Polyureth |
| H965440370 | Xcela Plus Plastic Port with PASV Valve Technology (Non-Filled Suture Holes) and 6F x 63cm Polyu |
| H965440350 | Xcela Plus Titanium Port with Non-Filled Suture Holes and 8F x 63cm Polyurethane Catheter |
| H965440330 | Xcela Plus Titanium Port with Non-Filled Suture Holes and 6F x 63cm Polyurethane Catheter |
| H965440320 | Xcela Plus Plastic Port with Filled Suture Holes and 8F x 63cm Polyurethane Catheter |
| H965440310 | Xcela Plus Plastic Port with Non-Filled Suture Holes and 8F x 63cm Polyurethane Catheter |
| H965440300 | Xcela Plus Plastic Port with Filled Suture Holes and 6F x 63cm Polyurethane Catheter |
| H965440290 | Xcela Plus Plastic Port with Non-Filled Suture Holes and 6F x 63cm Polyurethane Catheter |
| H96560M1404720 | PICC Convenience Kit |
| H96560M1404711 | PICC Convenience Kit |
| H96560M1404231 | PICC Convenience Kit |
| H96560M1401231 | PICC Convenience Kit |
| H96560M1379051 | PICC Convenience Kit |
| H96560M1369931 | PICC Convenience Kit |
| H96560M1369921 | PICC Convenience Kit |
| H96560M1369911 | PICC Convenience Kit |
| H96560M1367241 | PICC Convenience Kit |
| H96560M1367231 | PICC Convenience Kit |
| H96560M1309061 | PICC Convenience Kit |
| H96560M1309051 | PICC Convenience Kit |
| H96560M1309041 | PICC Convenience Kit |
| H96560M1309031 | PICC Convenience Kit |
| H96560M1216831 | PICC Convenience Kit |
| H96560M1216821 | PICC Convenience Kit |
| H96560M1216811 | PICC Convenience Kit |
| H96560M1205371 | PICC Convenience Kit |
| H96560M1201951 | PICC Convenience Kit |
| H96560M1201941 | PICC Convenience Kit |
| H96560M1201931 | PICC Convenience Kit |
| H96560M1109121 | PICC Convenience Kit |
| H96560M1009221 | PICC Convenience Kit |
| H96560M1009211 | PICC Convenience Kit |
| H96560M0908111 | PICC Convenience Kit |
| H96560M0800431 | PICC Convenience Kit |
| H96560M0623421 | PICC Convenience Kit |
| H96560M0623411 | PICC Convenience Kit |
| H96560M0501131 | PICC Convenience Kit |
| H96560M0501121 | PICC Convenience Kit |
| H96560M0501111 | PICC Convenience Kit |
| H96560M0411511 | PICC Convenience Kit |
Trademark Results [Xcela]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XCELA 98560873 not registered Live/Pending |
Xcela, Inc. 2024-05-21 |
 XCELA 86456391 not registered Live/Pending |
Essenlix Corporation 2014-11-17 |
 XCELA 77082290 3363005 Live/Registered |
NAVILYST MEDICAL, INC. 2007-01-12 |
 XCELA 74130696 not registered Dead/Abandoned |
Kirschner, Alexander 1991-01-15 |
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