AccessGUDID - DEVICE: POWERWAND™ XL (10859821006237)

GUDID

Device Identifier (DI) Information

Brand Name: POWERWAND™ XL
Version or Model: Max Barrier Kit 5Fr X 8cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 94116
Company Name: ICU MEDICAL, INC.

Primary DI Number: 10859821006237
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118380146 *Terms of Use

Device Description: POWERWAND™ XL Max Barrier Kit 5Fr X 8cm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40601	Peripheral vascular catheter	A 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OWL	Peripheral Catheter Insertion Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit
Special Storage Condition, Specify: Protect from direct contact with sun, water and humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 8 Centimeter
Catheter Gauge: 5 French

Device Record Status

Public Device Record Key: 694b5e6a-7479-4df8-8bb2-b12a02f45391
Public Version Date: March 18, 2025
Public Version Number: 3
DI Record Publish Date: September 09, 2016