EvenMore
GUDID H787103035125
14.5F x 22cm Chronic Hemodialysis Catheter Set (with Cuff 17cm from Tip)
ANGIODYNAMICS, INC.
Double-lumen haemodialysis catheter, implantable| Primary Device ID | H787103035125 |
| NIH Device Record Key | c133fbb6-9997-4642-837a-a4c8a9000915 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EvenMore |
| Version Model Number | 10303512 |
| 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 |
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 |
Device Dimensions
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
| Length | 22 Centimeter |
| Needle Gauge | 18 Gauge |
| Catheter Gauge | 14.5 French |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684014366 [Secondary] |
| HIBCC | H787103035120 [Primary] |
| HIBCC | H787103035125 [Package] Contains: H787103035120 Package: BOX [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K040402
FDA Product Code
| MSD | Catheter, hemodialysis, implanted |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-04-25 |
| Device Publish Date | 2015-09-15 |
On-Brand Devices [EvenMore]
| H787103036065 | 14.5F x 55cm EvenMore Straight Hemodialysis Catheter (with Cuff 50cm from Tip) |
| H787103036035 | 14.5F x 32cm EvenMore Straight Hemodialysis Catheter (with Cuff 27cm from Tip) |
| H787103036025 | 14.5F x 28cm EvenMore Straight Hemodialysis Catheter (with Cuff 23cm from Tip) |
| H787103036015 | 14.5F x 24cm EvenMore Straight Hemodialysis Catheter (with Cuff 19cm from Tip) |
| H787103035125 | 14.5F x 22cm Chronic Hemodialysis Catheter Set (with Cuff 17cm from Tip) |
| H787103035115 | 14.5F x 20cm Chronic Hemodialysis Catheter Set (with Cuff 15cm from Tip) |
| H787103035105 | 14.5F x 36cm Chronic Hemodialysis Pre-Curve Catheter Set (with Cuff 31cm from Tip) |
| H787103035095 | 14.5F x 32cm Chronic Hemodialysis Pre-Curve Catheter Set (with Cuff 27cm from Tip) |
| H787103035085 | 14.5F x 28cm Chronic Hemodialysis Pre-Curve Catheter Set (with Cuff 23cm from Tip) |
| H787103035075 | 14.5F x 24cm Chronic Hemodialysis Pre-Curve Catheter Set (with Cuff 19cm from Tip) |
| H787103035055 | 14.5F x 40cm Chronic Hemodialysis Catheter Set (with Cuff 35cm from Tip) |
| H787103035035 | 14.5F x 32cm Chronic Hemodialysis Catheter Set (with Cuff 27cm from Tip) |
| H787103035025 | 14.5F x 28cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip) |
| H787103035015 | 14.5F x 24cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip) |
| H787103035065 | 14.5F x 55cm Chronic Hemodialysis Catheter Set (with Cuff 50cm from Tip) |
| H787103035045 | 14.5F x 36cm Chronic Hemodialysis Catheter Set (with Cuff 31cm from Tip) |
| H787103036125 | 14.5F x 22cm EvenMore Straight Hemodialysis Catheter (with Cuff 17cm from Tip) |
| H787103036115 | 14.5F x 20cm EvenMore Straight Hemodialysis Catheter (with Cuff 15cm from Tip) |
| H787103036105 | 14.5F x 36cm EvenMore Pre-Curve Hemodialysis Catheter (with Cuff 31cm from Tip) |
| H787103036095 | 14.5F x 32cm EvenMore Pre-Curve Hemodialysis Catheter (with Cuff 27cm from Tip) |
| H787103036085 | 14.5F x 28cm EvenMore Pre-Curve Hemodialysis Catheter (with Cuff 23cm from Tip) |
| H787103036075 | 14.5F x 24cm EvenMore Pre-Curve Hemodialysis Catheter (with Cuff 19cm from Tip) |
| H787103036055 | 14.5F x 40cm EvenMore Straight Hemodialysis Catheter (with Cuff 35cm from Tip) |
| H787103036045 | 14.5F x 36cm EvenMore Straight Hemodialysis Catheter (with Cuff 31cm from Tip) |
Trademark Results [EvenMore]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVENMORE 76583628 2978022 Live/Registered |
AngioDynamics, Inc. 2004-03-29 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.