AccessGUDID - DEVICE: Irrigation Set (10887787006701)

GUDID

Device Identifier (DI) Information

Brand Name: Irrigation Set
Version or Model: 654101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0654101
Company Name: ICU MEDICAL FLEET SERVICES, LLC

Primary DI Number: 10887787006701
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830767898 *Terms of Use

Device Description: LATEX-FREE SECONDARY IRRIGATION SET For Series Hookup For Use with Flexible Container Irrigation Systems (previously Hospira product)

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:	No
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?
34930	Single-administration urethral drainage/irrigation catheter	A sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder to provide one episode of irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBX	CATHETER, IRRIGATION

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Room Temperature. Avoid Excessive Heat. Protect from Freezing

Clinically Relevant Size

[?]

Size Type Text
Length: 26 Inch

Device Record Status

Public Device Record Key: 478c773b-de91-4432-9786-8f0cee7327a6
Public Version Date: July 30, 2018
Public Version Number: 1
DI Record Publish Date: June 28, 2018