FDA.reportPublic FDA data

POWERWAND™ XL-REC

Primary DI
10859821006510
Brand
POWERWAND™ XL-REC
Company
ICU MEDICAL, INC.
Model
4Fr x 6cm
Catalog number
95001
Device description
The POWERWAND XL-REC Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque
Published
2017-05-30
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
K131300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131300000THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETERAccess Scientific, LLC2013-06-07DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20859821006517PackageGS110In Commercial Distribution
30859821006514PackageGS112In Commercial Distribution
10859821006510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085982100651720859821006517
3085982100651430859821006514
1085982100651010859821006510

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
Length6Centimeter

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
118380146
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
10887709197265BivonaZU26FN35NGE229N2026-07-09
10887709197289BivonaFT26FN70NSZ232N2026-07-09
10887709197838BivonaFT26GN55NGF037N2026-07-09
10887709197845BivonaST26GN55NGF038N2026-07-09
10887709197852BivonaFT26GN35NSF039N2026-07-09
10887709197869BivonaFT26GN35NSF043N2026-07-09
10887709197876BivonaFT26GN40NSF042N2026-07-09
10887709197883BivonaFU26GN35NGE044N2026-07-09
10887709197890BivonaFU26GN30NGE045N2026-07-09
10887709197906BivonaFP26GN25NGE046N2026-07-09
10887709197135BivonaXT26FS60NGC231N2026-07-08
10887709197142BivonaFT26FN35NGC234N2026-07-08
10887709197203BivonaFT26FN55NGC237N2026-07-08
10887709197210BivonaFT26FN35NSF236N2026-07-08
10887709197227BivonaFT26FN40NGE238N2026-07-08
10887709197234BivonaFT26FN40NGE239N2026-07-08
10887709197241BivonaFT26FN60NGC240N2026-07-08
10887709197722BivonaHT26GS70NSC029N2026-07-08
10887709197739BivonaFT26GN35NSE030N2026-07-08
10887709197746BivonaFT26GN30NSF031N2026-07-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
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07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
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00813502010664Introducer Kit for Impella®Oscor Inc.DYB2017-11-30
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H965481080NavylistNAVILYST MEDICAL, INC.DYB2017-08-07
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H965355020ENVINAVILYST MEDICAL, INC.DYB2017-08-07
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