Primary Device ID | H787103011025 |
NIH Device Record Key | f1dbc163-d39f-448e-8a03-d179c787d1aa |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DuraFlow |
Version Model Number | 10301102 |
Company DUNS | 079105071 |
Company Name | ANGIODYNAMICS, 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 |
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 |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Length | 28 Centimeter |
Needle Gauge | 18 Gauge |
Catheter Gauge | 15.5 French |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | H787103011020 [Primary] |
HIBCC | H787103011025 [Package] Contains: H787103011020 Package: BOX [5 Units] In Commercial Distribution |
MSD | Catheter, hemodialysis, implanted |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2015-09-15 |
H787103018015 | HemoDialysis Catheter Repair Kit |
H787103017155 | DuraFlow 2 - 15.5F x 48cm DuraFlow2 Hemodialysis Catheter (with Cuff 43cm from Tip) |
H787103017145 | DuraFlow 2 - 15.5F x 55cm DuraFlow2 Hemodialysis Catheter (with Cuff 50cm from Tip) |
H787103017135 | DuraFlow 2 - 15.5F x 22cm DuraFlow2 Hemodialysis Catheter (with Cuff 17cm from Tip) |
H787103017115 | DuraFlow 2 - 15.5F x 20cm DuraFlow2 Hemodialysis Catheter (with Cuff 15cm from Tip) |
H787103017055 | DuraFlow 2 - 15.5F x 40cm DuraFlow2 Hemodialysis Catheter (with Cuff 35cm from Tip) |
H787103017045 | DuraFlow 2 - 15.5F x 36cm DuraFlow2 Hemodialysis Catheter (with Cuff 31cm from Tip) |
H787103017035 | DuraFlow 2 - 15.5F x 32cm DuraFlow2 Hemodialysis Catheter (with Cuff 27cm from Tip) |
H787103017025 | DuraFlow 2 - 15.5F x 28cm DuraFlow2 Hemodialysis Catheter (with Cuff 23cm from Tip) |
H787103017015 | DuraFlow 2 - 15.5F x 24cm DuraFlow2 Hemodialysis Catheter (with Cuff 19cm from Tip) |
H787103014035 | Dura-Flow Tunneling Trocar |
H787103012245 | DuraFlow 2 - 15.5F x 55cm Chronic Hemodialysis VascPak Kit (with Cuff 50cm from Tip) |
H787103012235 | DuraFlow 2 - 15.5F x 48cm Chronic Hemodialysis VascPak Kit (with Cuff 43cm from Tip) |
H787103012225 | DuraFlow 2 - 15.5F x 40cm Chronic Hemodialysis VascPak Kit (with Cuff 35cm from Tip) |
H787103012215 | DuraFlow 2 - 15.5F x 36cm Chronic Hemodialysis VascPak Kit (with Cuff 31cm from Tip) |
H787103012205 | DuraFlow 2 - 15.5F x 32cm Chronic Hemodialysis VascPak Kit (with Cuff 27cm from Tip) |
H787103012195 | DuraFlow 2 - 15.5F x 28cm Chronic Hemodialysis VascPak Kit (with Cuff 23cm from Tip) |
H787103012185 | DuraFlow 2 - 15.5F x 24cm Chronic Hemodialysis VascPak Kit (with Cuff 19cm from Tip) |
H787103012175 | DuraFlow 2 - 15.5F x 22cm Chronic Hemodialysis VascPak Kit (with Cuff 17cm from Tip) |
H787103012165 | DuraFlow 2 - 15.5F x 20cm Chronic Hemodialysis VascPak Kit (with Cuff 15cm from Tip) |
H787103012155 | DuraFlow 2 - 15.5F x 48cm Chronic Hemodialysis Catheter Set (with Cuff 43cm from Tip) |
H787103012145 | DuraFlow 2 - 15.5F x 20cm Chronic Hemodialysis Catheter Set (with Cuff 15cm from Tip) |
H787103012135 | 15.5F x 20cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 15cm from |
H787103012125 | DuraFlow 2 - 15.5F x 22cm Chronic Hemodialysis Catheter Set (with Cuff 17cm from Tip) |
H787103012115 | DuraFlow 2 - 15.5F x 55cm Chronic Hemodialysis Catheter Set (with Cuff 50cm from Tip) |
H787103012095 | 15.5F x 36cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 31cm from |
H787103012085 | 15.5F x 32cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 27cm from |
H787103012075 | 15.5F x 28cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 23cm from |
H787103012065 | 15.5F x 24cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 19cm from |
H787103012055 | DuraFlow 2 - 15.5F x 40cm Chronic Hemodialysis Catheter Set (with Cuff 35cm from Tip) |
H787103012045 | DuraFlow 2 - 15.5F x 36cm Chronic Hemodialysis Catheter Set (with Cuff 31cm from Tip) |
H787103012035 | DuraFlow 2 - 15.5F x 32cm Chronic Hemodialysis Catheter Set (with Cuff 27cm from Tip) |
H787103012025 | DuraFlow 2 - 15.5F x 28cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip) |
H787103012015 | DuraFlow 2 - 15.5F x 24cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip) |
H787103011085 | 15.5F x 32cm Dura-Flow Pre-Curve with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 27cm from |
H787103011035 | 15.5F x 32cm Dura-Flow with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 27cm from Tip) |
H787103011025 | 15.5F x 28cm Dura-Flow with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 23cm from Tip) |
H787103011015 | 15.5F x 24cm Dura-Flow with Hydro-Tip Hemodialysis Catheter Tray (with Cuff 19cm from Tip) |
H787103003015 | 7F Double Access Hemodialysis Set |