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 Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable 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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