POWERWAND XL 94123

GUDID 20859821006470

POWERWAND XL Quick Kit 3Fr X 6cm

ICU MEDICAL, INC.

Peripheral vascular catheter
Primary Device ID20859821006470
NIH Device Record Key97ed1e02-6765-4a89-bdbe-d1625abef80a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOWERWAND XL
Version Model NumberQuick Kit 3Fr X 6cm
Catalog Number94123
Company DUNS118380146
Company NameICU MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-858-259-8333
Emailcs@accessscientific.com
Phone1-858-259-8333
Emailcs@accessscientific.com
Phone1-858-259-8333
Emailcs@accessscientific.com
Phone1-858-259-8333
Emailcs@accessscientific.com
Phone1-858-259-8333
Emailcs@accessscientific.com
Phone1-858-259-8333
Emailcs@accessscientific.com
Phone1-858-259-8333
Emailcs@accessscientific.com
Phone1-858-259-8333
Emailcs@accessscientific.com
Phone1-858-259-8333
Emailcs@accessscientific.com
Phone1-858-259-8333
Emailcs@accessscientific.com
Phone1-858-259-8333
Emailcs@accessscientific.com
Phone1-858-259-8333
Emailcs@accessscientific.com
Phone1-858-259-8333
Emailcs@accessscientific.com
Phone1-858-259-8333
Emailcs@accessscientific.com

Device Dimensions

Length6 Centimeter
Catheter Gauge3 French
Length6 Centimeter
Catheter Gauge3 French
Length6 Centimeter
Catheter Gauge3 French
Length6 Centimeter
Catheter Gauge3 French
Length6 Centimeter
Catheter Gauge3 French
Length6 Centimeter
Catheter Gauge3 French
Length6 Centimeter
Catheter Gauge3 French
Length6 Centimeter
Catheter Gauge3 French
Length6 Centimeter
Catheter Gauge3 French
Length6 Centimeter
Catheter Gauge3 French
Length6 Centimeter
Catheter Gauge3 French
Length6 Centimeter
Catheter Gauge3 French
Length6 Centimeter
Catheter Gauge3 French
Length6 Centimeter
Catheter Gauge3 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from direct contact with sun, water and humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110859821006473 [Primary]
GS120859821006470 [Package]
Contains: 10859821006473
Package: Carton [10 Units]
In Commercial Distribution

FDA Product Code

OWLPeripheral Catheter Insertion Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-03-18
Device Publish Date2017-02-28

On-Brand Devices [POWERWAND XL]

20859821006470POWERWAND XL Quick Kit 3Fr X 6cm
30859821006101The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transiti

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