FDA.reportPublic FDA data

PICC WAND

Primary DI
10859821006145
Brand
PICC WAND
Company
ACCESS SCIENTIFIC, LLC
Model
5Fr
Catalog number
91008
Device description
The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111138000THE PICC WAND (R) PEELABLE SAFETY INTRODUCERAccess Scientific, Inc.2011-06-22DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20859821006142PackageGS110In Commercial Distribution
30859821006149PackageGS118In Commercial Distribution
10859821006145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085982100614220859821006142
3085982100614930859821006149
1085982100614510859821006145

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 Gauge5French
Length7.25Centimeter

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
10859821006121CVC WAND XL7Fr931022016-09-09
10859821006138PICC WAND4Fr910102016-09-09
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

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Primary DI, Brand, Company table
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08498840011812VYGONVygon CorporationDYB2019-04-08
08498840012215VYGONVygon CorporationDYB2019-04-08
H965481030ENVINAVILYST MEDICAL, INC.DYB2019-01-03
07613327459210AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDYB2018-10-26
00813502010664Introducer Kit for Impella®Oscor Inc.DYB2017-11-30
00813502010237Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010244Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
00813502010558Introducer Kit for Impella®Oscor Inc.DYB2017-11-18
H965481080NavylistNAVILYST MEDICAL, INC.DYB2017-08-07
H965355010ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355020ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355030ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355060ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355080ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355090ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355110ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355120ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355130ENVINAVILYST MEDICAL, INC.DYB2017-08-07