FDA.reportPublic FDA data

CVC WAND XL

Primary DI
10859821006121
Brand
CVC WAND XL
Company
ACCESS SCIENTIFIC, LLC
Model
7Fr
Catalog number
93102
Device description
The CVC WAND Safety Introducer with Valved Peelabel Sheath
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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20859821006128PackageGS110In Commercial Distribution
30859821006125PackageGS118In Commercial Distribution
10859821006121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085982100612820859821006128
3085982100612530859821006125
1085982100612110859821006121

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of 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 Gauge7French
Length6Centimeter

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
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
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
10859821006756POWERWAND W/Statlock717522019-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884450489823Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489830Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489847Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489854Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489861Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489878Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489885Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489892Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489908Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
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10884450489922Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489939Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489946Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
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10884450489977Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450489984Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450510602Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510640Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510664Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27