FDA.reportPublic FDA data

POWERWAND™ XL Maximum Barrier Kit

Primary DI
10859821006770
Brand
POWERWAND™ XL Maximum Barrier Kit
Company
ACCESS SCIENTIFIC, LLC
Model
4 Fr
Catalog number
94108
Device description
POWERWAND™ XL Maximum Barrier Kit, 4Fr x 10cm
Published
2019-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859821006770PackageGS110In Commercial Distribution
00859821006773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085982100677010859821006770
00859821006773008598210067738598210067730859821006773

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French
Catheter Length10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature33 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079290879
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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