POWERWAND™ XL 94108
GUDID 10859821006800
POWERWAND XL Maximum Barrier Kit 4Fr x 10cm without Statlock and IV Extension Set
ACCESS SCIENTIFIC, LLC
Vascular catheter introduction set, nonimplantable| Primary Device ID | 10859821006800 |
| NIH Device Record Key | d8e26430-f6b0-4d08-b422-fdefb0b0cffd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POWERWAND™ XL |
| Version Model Number | Maximum Barrier Kit 4Fr x 10cm |
| Catalog Number | 94108 |
| 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 |
Device Dimensions
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Working Length | 10 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 |
| 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 | 00859821006803 [Primary] |
| GS1 | 10859821006800 [Package] Contains: 00859821006803 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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-08 |
| Device Publish Date | 2020-09-30 |
On-Brand Devices [POWERWAND™ XL]
| 00859821006681 | The POWERWAND™ XL Introducer with Extended Dwell Catheter, 4Fr x 10cm |
| 10859821006800 | POWERWAND XL Maximum Barrier Kit 4Fr x 10cm without Statlock and IV Extension Set |
| 00859821006810 | Pouch, PW XL 3FR 6cm (US) for Kit (40351) |
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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