FDA.reportPublic FDA data

POWERWAND™ XL

Primary DI
10859821006435
Brand
POWERWAND™ XL
Company
ACCESS SCIENTIFIC, LLC
Model
Basic Kit 4Fr X 10cm
Catalog number
80801
Device description
POWERWAND™ XL Basic Kit 4Fr X 10cm
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWLPeripheral Catheter Insertion Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWLPeripheral Catheter Insertion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20859821006432PackageGS110In Commercial Distribution
10859821006435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085982100643220859821006432
1085982100643510859821006435

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular catheterA sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French
Length10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from direct contact with sun, water and humidity
Storage Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-858-259-8333cs@accessscientific.com

Regulatory Flags#

DUNS number
079290879
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10859821006374POWERWANDDressing Change Kit with StatLock716972016-09-09
10859821006381POWERWANDDressing Change Kit with Zpad717012016-09-09
10859821006459POWERWANDDeluxe Dressing Change kit w/ Zpad717512016-09-09
00859821006759POWERWAND W/Statlock717522019-12-12
10859821006114CVC WAND7Fr930012016-09-09
10859821006121CVC WAND XL7Fr931022016-09-09
10859821006138PICC WAND4Fr910102016-09-09
10859821006145PICC WAND5Fr910082016-09-09
10859821006152PICC WAND6Fr910122016-09-09
10859821006398PICC WAND Max Barrier Kit 4Fr718772016-09-09
10859821006404PICC WAND Max Barrier Kit 5Fr 718762016-09-09
10859821006411PICC WAND Max Barrier Kit 6Fr 718782016-09-09
00859821006704CVC WAND 7Fr X 6cm930012018-10-11
00859821006711CVC WAND XL 7Fr X 6cm931022018-10-11
00859821006797POWERWANDED Quick Kit 3Fr x 6cm (Custom)726412020-03-25
00859821006803POWERWAND™ XLMaximum Barrier Kit 4Fr x 10cm941082020-09-30
10859821006794POWERWANDED Quick Kit 3Fr x 6cm (Custom)726412020-03-25
00859821006810POWERWAND™ XL3Fr x 6cm403512020-11-06
00859821006780POWERWANDED 3Fr x 6cm (Custom)404592020-03-25
10859821006800POWERWAND™ XLMaximum Barrier Kit 4Fr x 10cm941082020-09-30

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