POWERWAND™ XL 94102
GUDID 30859821006019
The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque
ICU MEDICAL, INC.
Peripheral vascular catheter| Primary Device ID | 30859821006019 |
| NIH Device Record Key | c89b4aae-b3a0-460f-8194-273bbc148c22 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POWERWAND™ XL |
| Version Model Number | 4Fr x 8cm |
| Catalog Number | 94102 |
| Company DUNS | 118380146 |
| Company Name | ICU 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-858-259-8333 |
| cs@accessscientific.com | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com |
Device Dimensions
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
| Length | 8 Centimeter |
| Catheter Gauge | 4 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10859821006015 [Primary] |
| GS1 | 20859821006012 [Package] Contains: 10859821006015 Package: Carton [10 Units] In Commercial Distribution |
| GS1 | 30859821006019 [Package] Contains: 20859821006012 Package: Overpack [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131300
FDA Product Code
| DYB | Introducer, Catheter |
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 | 2025-03-18 |
| Device Publish Date | 2016-09-09 |
On-Brand Devices [POWERWAND™ XL]
| 20859821006548 | POWERWAND™ XL Quick Kit 5Fr X 10cm Bifurcated |
| 30859821006538 | The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transiti |
| 20859821006258 | POWERWAND™ XL Quick Kit 5Fr X 10cm |
| 20859821006234 | POWERWAND™ XL Max Barrier Kit 5Fr X 8cm |
| 20859821006227 | POWERWAND™ XL Quick Kit 5Fr X 8cm |
| 20859821006210 | POWERWAND™ XL Alt Site Kit 4Fr X 10cm |
| 20859821006203 | POWERWAND™ XL Max Barrier Kit 4Fr X 10cm |
| 20859821006197 | POWERWAND™ XL Quick Kit 4Fr X 10cm |
| 20859821006173 | POWERWAND™ XL Max Barrier Kit 4Fr X 8cm |
| 20859821006166 | Quick Kit 4Fr X 8cm |
| 30859821006040 | The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transiti |
| 30859821006033 | The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transiti |
| 30859821006026 | The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transiti |
| 30859821006019 | The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transiti |
Trademark Results [POWERWAND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POWERWAND 88872007 not registered Live/Pending |
Water Pik, Inc. 2020-04-14 |
 POWERWAND 87321321 not registered Dead/Abandoned |
Hunter Douglas Inc. 2017-02-01 |
 POWERWAND 77558485 3904769 Live/Registered |
ACCESS SCIENTIFIC, LLC 2008-08-28 |
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