AccessGUDID - DEVICE: Irrigation Set (10887787006732)

GUDID

Device Identifier (DI) Information

Brand Name: Irrigation Set
Version or Model: 654401
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0654401
Company Name: ICU MEDICAL FLEET SERVICES, LLC

Primary DI Number: 10887787006732
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830767898 *Terms of Use

Device Description: LATEX-FREE CYSTOSCOPY/IRRIGATION SET Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation For Use with Flexible Irrigation Container System (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?
58752	Arthroscopic access cannula, single-use	A single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. 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: 77 Inch

Device Record Status

Public Device Record Key: d90797cd-caf6-4697-a9d9-080f943e088a
Public Version Date: January 23, 2019
Public Version Number: 2
DI Record Publish Date: May 31, 2018