FDA.reportPublic FDA data

POWERWAND™ XL

Primary DI
10859821006015
Brand
POWERWAND™ XL
Company
ICU MEDICAL, INC.
Model
4Fr x 8cm
Catalog number
94102
Device description
The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque
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
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
20859821006012PackageGS110In Commercial Distribution
30859821006019PackageGS112In Commercial Distribution
10859821006015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085982100601220859821006012
3085982100601930859821006019
1085982100601510859821006015

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
Length8Centimeter

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
10887709199870BivonaFU26GN40NSC236N2026-07-30
10887709199887BivonaFU26GN30NSC235N2026-07-30
10887709199894BivonaFU26GN30NSF235N2026-07-30
10887709199689BivonaFU26GN60NGF229N2026-07-29
10887709199696BivonaFT26GN45NSF228N2026-07-29
10887709199702BivonaST26GN50NGF231N2026-07-29
10887709199719BivonaFT26GN40NGF230N2026-07-29
10887709199726BivonaFT26GN65NSC225N2026-07-29
10887709199733BivonaSU26GN45NSC223N2026-07-29
10887709199740BivonaSU26GN40NSC222N2026-07-29
10887709199757BivonaFT26GN60NSF232N2026-07-29
10887709199658BivonaFT26GN25NSA221N2026-07-28
10887709199665BivonaST26GN55NSB224N2026-07-28
10887709198804BivonaFT26GN45NSF145N2026-07-27
10887709199252BivonaFU26GN50NSF160N2026-07-27
10887709199269BivonaFT26GN55NGF161N2026-07-27
10887709199276BivonaFP26GN40NSF163N2026-07-27
10887709199283BivonaFU26GN45NSA164N2026-07-27
10887709199290BivonaFT26GN40NGE162N2026-07-27
10887709199306BivonaFT26FN80NSC026S2026-07-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902196528ARROWTELEFLEX INCORPORATEDDYB2026-07-30
10801902200768ARROWTELEFLEX INCORPORATEDDYB2026-07-30
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