POWERWAND 92019
GUDID 30859821006521
The POWERWAND-ED. Safety Introducer with Extended Dwell Catheter and Integral Needle Protection. *Fast-flash. *ZERO-EDGE Transitions. *Power Injectable
ICU MEDICAL, INC.
Peripheral vascular catheter| Primary Device ID | 30859821006521 |
| NIH Device Record Key | aad0eec5-4272-4765-8d42-d32c54ee44dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POWERWAND |
| Version Model Number | (ED) 3 Fr X 6 cm |
| Catalog Number | 92019 |
| 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 | 6 Centimeter |
| Catheter Gauge | 3 French |
| Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Length | 6 Centimeter |
| Catheter Gauge | 3 French |
Operating and Storage Conditions
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 |
| Storage 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 | 10859821006527 [Primary] |
| GS1 | 20859821006524 [Package] Contains: 10859821006527 Package: Carton [10 Units] In Commercial Distribution |
| GS1 | 30859821006521 [Package] Contains: 20859821006524 Package: Overpack [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162322
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 |
On-Brand Devices [POWERWAND]
| 30859821006521 | The POWERWAND-ED. Safety Introducer with Extended Dwell Catheter and Integral Needle Protection. |
| 20859821006357 | POWERWAND Max Barrier Kit 5Fr X 10cm |
| 20859821006340 | POWERWAND Quick Kit 5Fr X 10cm |
| 30859821006088 | The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle P |
| 30859821006071 | The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle P |
| 20859821006067 | The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle P |
| 30859821006057 | The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle P |
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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