POWERWAND™ XL-REC 95001
GUDID 30859821006514
The POWERWAND XL-REC Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque
ICU MEDICAL, INC.
Peripheral vascular catheter| Primary Device ID | 30859821006514 |
| NIH Device Record Key | 4f373b04-0b9f-4bb1-81d5-ef8a774cc1f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POWERWAND™ XL-REC |
| Version Model Number | 4Fr x 6cm |
| Catalog Number | 95001 |
| 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
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
| Catheter Gauge | 4 French |
| Length | 6 Centimeter |
Operating and Storage Conditions
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct contact with sun, water and humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10859821006510 [Primary] |
| GS1 | 20859821006517 [Package] Contains: 10859821006510 Package: Shipper Box [10 Units] In Commercial Distribution |
| GS1 | 30859821006514 [Package] Contains: 20859821006517 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 | 2017-05-30 |
Devices Manufactured by ICU MEDICAL, INC.
| 10887709179100 - Bivona | 2025-12-09 FT25KN35NSE251S Bivona DI: Non-Adjustable-Wired-Sterile |
| 10887709179117 - Bivona | 2025-12-09 FT25KN35NSE250S Bivona DI: Non-Adjustable-Wired-Sterile |
| 10887709179124 - Bivona | 2025-12-09 FU25KN45NGF252N Bivona DI: Non-Adjustable-Wired_Non-Sterile |
| 10887709179131 - Bivona | 2025-12-09 ST25KN70NSC253N Bivona DI: Non-Adjustable-Wired_Non-Sterile |
| 10887709179148 - Bivona | 2025-12-09 FT25KN45NSF254N Bivona DI: Non-Adjustable-Wired_Non-Sterile |
| 10887709179155 - Bivona | 2025-12-09 FT25LN40NGE001N Bivona DI: Non-Adjustable-Wired_Non-Sterile |
| 10887709179162 - Bivona | 2025-12-09 FT25LN35NSE002N Bivona DI: Non-Adjustable-Wired_Non-Sterile |
| 10887709179179 - Bivona | 2025-12-09 ST25DN75NSC297N Bivona DI: Non-Adjustable-Wired_Non-Sterile |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.