POWERWAND XL

Primary DI
30859821006101
Brand
POWERWAND XL
Company
ICU MEDICAL, INC.
Model
3Fr x 6cm
Catalog number
94122
Device description
The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque
Published
2017-02-28
Public version status
Update
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#

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162322000the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC2016-11-17DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20859821006104PackageGS110In Commercial Distribution
30859821006101PackageGS112In Commercial Distribution
10859821006107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085982100610420859821006104
3085982100610130859821006101
1085982100610710859821006107

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 Gauge3French
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
false
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

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Primary DI, Brand, Company table
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