POWERWAND 72641
GUDID 10859821006794
POWERWAND™ ED Quick Kit 3Fr x 6cm (Custom)
ACCESS SCIENTIFIC, LLC
Vascular catheter introduction set, nonimplantable| Primary Device ID | 10859821006794 |
| NIH Device Record Key | 65b2684f-f06e-4523-8d3e-ce9150ed0518 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POWERWAND |
| Version Model Number | ED Quick Kit 3Fr x 6cm (Custom) |
| Catalog Number | 72641 |
| Company DUNS | 079290879 |
| Company Name | ACCESS SCIENTIFIC, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | |
| 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 | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
| Catheter Gauge | 3 French |
| Catheter Working Length | 6 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859821006797 [Primary] |
| GS1 | 10859821006794 [Package] Contains: 00859821006797 Package: Carton [10 Units] In Commercial Distribution |
FDA Product Code
| OWL | Peripheral Catheter Insertion Kit |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-03-20 |
| Device Publish Date | 2020-03-25 |
On-Brand Devices [POWERWAND]
| 00859821006674 | POWERWAND™ ED Quick Kit 3FR 6cm |
| 20859821006456 | Deluxe Dressing Change Kit W/Zpad |
| 20859821006388 | POWERWAND Dressing Change Kit with Zpad |
| 20859821006371 | POWERWAND Dressing Change Kit with StatLock |
| 10859821006756 | Dressing Change Kit w/Statlock |
| 00859821006780 | POWERWAND™ ED 3Fr x 6cm (Custom) |
| 10859821006794 | POWERWAND™ ED Quick Kit 3Fr x 6cm (Custom) |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.