POWERWAND™ XL Alternate Site with Needle Guide Kit 80757
GUDID 10859821006763
POWERWAND™ XL Alternate Site with Needle Guide Kit
ACCESS SCIENTIFIC, LLC
Vascular catheter introduction set, nonimplantable| Primary Device ID | 10859821006763 |
| NIH Device Record Key | 4629db6e-2e89-44f1-9c96-80e799a1f0e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POWERWAND™ XL Alternate Site with Needle Guide Kit |
| Version Model Number | 4 Fr |
| Catalog Number | 80757 |
| 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 | |
| Phone | 1-858-259-8333 |
| cs@accessscientific.com |
Device Dimensions
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
| Catheter Length | 10 Centimeter |
| Catheter Gauge | 4 French |
Operating and Storage Conditions
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859821006766 [Primary] |
| GS1 | 10859821006763 [Package] Contains: 00859821006766 Package: [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 | 2019-12-13 |
| Device Publish Date | 2019-11-22 |
Devices Manufactured by ACCESS SCIENTIFIC, LLC
| 10859821006794 - POWERWAND | 2024-03-20 POWERWAND™ ED Quick Kit 3Fr x 6cm (Custom) |
| 00859821006810 - POWERWAND™ XL | 2024-03-20 Pouch, PW XL 3FR 6cm (US) for Kit (40351) |
| 10859821006800 - POWERWAND™ XL | 2020-10-08 POWERWAND XL Maximum Barrier Kit 4Fr x 10cm without Statlock and IV Extension Set |
| 00859821006780 - POWERWAND | 2020-04-28 POWERWAND™ ED 3Fr x 6cm (Custom) |
| 10859821006756 - POWERWAND | 2019-12-20 Dressing Change Kit w/Statlock |
| 10859821006763 - POWERWAND™ XL Alternate Site with Needle Guide Kit | 2019-12-13POWERWAND™ XL Alternate Site with Needle Guide Kit |
| 10859821006763 - POWERWAND™ XL Alternate Site with Needle Guide Kit | 2019-12-13 POWERWAND™ XL Alternate Site with Needle Guide Kit |
| 20859821006708 - CVC WAND | 2019-12-09 The CVC WAND Safety Introducer with Valved Peelable Sheath |
| 20859821006715 - CVC WAND XL | 2019-12-09 The CVC WAND Safety Introducer with Valved Peelable Sheath |
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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