BioFlo
GUDID H965PKM61008023S1
PICC Convenience Kit
NAVILYST MEDICAL, INC.
Peripherally-inserted central venous catheter| Primary Device ID | H965PKM61008023S1 |
| NIH Device Record Key | 791c9472-ff7d-4f2c-8510-1d69f9ec4de1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioFlo |
| Version Model Number | PKM61008023S |
| 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 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 | H965PKM61008023S0 [Primary] |
| HIBCC | H965PKM61008023S1 [Package] Contains: H965PKM61008023S0 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 | 4 |
| Public Version Date | 2021-02-19 |
| Device Publish Date | 2017-07-13 |
On-Brand Devices [BioFlo]
| H965PKM61058234S1 | PICC Convenience Kit |
| H96560M1303191 | PICC Convenience Kit |
| H96560M1303171 | PICC Convenience Kit |
| H96560M1303151 | PICC Convenience Kit |
| H96560M13031101 | PICC Convenience Kit |
| H965PKM220851S1 | PICC Convenience Kit |
| H965PKM1300011S1 | PICC Convenience Kit |
| H96560M0134211 | PICC Convenience Kit |
| H965PKM194923S1 | PICC Convenience Kit |
| H965PKM131934S1 | PICC Convenience Kit |
| H965PKM61102513S1 | PICC Convenience Kit |
| H965PKM61102512S1 | PICC Convenience Kit |
| H965PKM130343S1 | PICC Convenience Kit |
| H965750670 | BioFlo PICC with ENDEXO Technology (4F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated |
| H965750660 | BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Triple Lumen) - Maximal Bar |
| H965750650 | BioFlo PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Triple Lumen) - Maximal Barrier Du |
| H965750640 | BioFlo PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Dual Lumen) - Maximal Barrier Dual |
| H965750630 | BioFlo PICC with ENDEXO and PASV Valve Technology (5F x 55cm, Single Lumen) - Maximal Barrier Du |
| H965750620 | BioFlo PICC with ENDEXO and PASV Valve Technology (5F x 55cm, Single Lumen) - Maximal Barrier Du |
| H965750610 | BioFlo PICC with ENDEXO and PASV Valve Technology (4F x 55cm, Single Lumen) - Maximal Barrier Du |
| H965750600 | BioFlo PICC with ENDEXO Technology (6F x 55cm, Triple Lumen) - Maximal Barrier Dual Fenestrated |
| H965750590 | BioFlo PICC with ENDEXO Technology (6F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Dr |
| H965750580 | BioFlo PICC with ENDEXO Technology (5F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Dr |
| H965750570 | BioFlo PICC with ENDEXO Technology (5F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated |
| H965750560 | BioFlo PICC with ENDEXO Technology (4F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated |
| H965750550 | BioFlo PICC with ENDEXO Technology (6F x 55cm, Triple Lumen) - Maximal Barrier Dual Fenestrated |
| H965750540 | BioFlo PICC with ENDEXO Technology (3F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated |
| H965750530 | BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Triple Lumen) - Maximal Bar |
| H965750520 | BioFlo PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Triple Lumen) - Maximal Barrier Du |
| H965750510 | BioFlo PICC with ENDEXO and PASV Valve Technology (6F x 55cm, Dual Lumen) - Maximal Barrier Dual |
| H965750500 | BioFlo PICC with ENDEXO and PASV Valve Technology (5F x 55cm, Dual Lumen) - Maximal Barrier Dual |
| H965750490 | BioFlo PICC with ENDEXO and PASV Valve Technology (5F x 55cm, Single Lumen) - Maximal Barrier Du |
| H965750480 | BioFlo PICC with ENDEXO and PASV Valve Technology (4F x 55cm, Single Lumen) - Maximal Barrier Du |
| H965750470 | BioFlo PICC with ENDEXO and PASV Valve Technology (3F x 55cm, Single Lumen) - Maximal Barrier Du |
| H965750460 | BioFlo PICC with ENDEXO Technology (6F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated D |
| H965750450 | BioFlo PICC with ENDEXO Technology (5F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated D |
| H965750440 | BioFlo PICC with ENDEXO Technology (5F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated |
| H965460290 | BioFlo Midline with ENDEXO Technology (5F x 20cm, Dual Lumen) - Maximal Barrier Dual Fenestrate |
| H965460280 | BioFlo Midline with ENDEXO Technology (5F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestra |
| H965460270 | BioFlo Midline with ENDEXO Technology (4F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestra |
| H965460260 | BioFlo Midline with ENDEXO Technology (3F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestra |
| H965460250 | BioFlo Midline with ENDEXO Technology (5F x 20cm, Dual Lumen) - Maximal Barrier Dual Fenestrate |
| H965460240 | BioFlo Midline with ENDEXO Technology (5F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestra |
| H965460230 | BioFlo Midline with ENDEXO Technology (4F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestra |
| H965460220 | BioFlo Midline with ENDEXO Technology (3F x 20cm, Single Lumen) - Maximal Barrier Dual Fenestra |
| H965PKM1220222S1 | PICC Convenience Kit |
| H965PKM1220223S1 | PICC Convenience Kit |
| H965PKM1220224S1 | PICC Convenience Kit |
| H965PKM220854S1 | PICC Convenience Kit |
| H965PKM0116210S1 | PICC Convenience Kit |
Trademark Results [BioFlo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOFLO 98572768 not registered Live/Pending |
FloSpine 2024-05-28 |
 BIOFLO 98490320 not registered Live/Pending |
Allegheny Petroleum Products Company 2024-04-09 |
 BIOFLO 90038587 not registered Live/Pending |
Industrial Systems 2020-07-07 |
 BIOFLO 87649723 5485529 Live/Registered |
AngioDynamics, Inc. 2017-10-18 |
 BIOFLO 86893560 5103418 Live/Registered |
AngioDynamics, Inc. 2016-02-01 |
 BIOFLO 86729361 not registered Dead/Abandoned |
AngioDynamics, Inc. 2015-08-19 |
 BIOFLO 86423436 4751648 Live/Registered |
AngioDynamics, Inc. 2014-10-14 |
 BIOFLO 85564026 4362153 Live/Registered |
Bioflo, Inc. 2012-03-08 |
 BIOFLO 85179751 4350554 Live/Registered |
BIOFLO LLC 2010-11-18 |
 BIOFLO 76497412 2977255 Dead/Cancelled |
HYDOR S.R.L. 2003-03-14 |
 BIOFLO 76469903 2779330 Live/Registered |
EPPENDORF, INC. 2002-11-25 |
 BIOFLO 76209114 2687961 Live/Registered |
Allegheny Bradford Corporation 2001-02-12 |
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