Irrigation Set 0654101

GUDID 20887787006708

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

ICU MEDICAL FLEET SERVICES, LLC

Single-administration urethral drainage/irrigation catheter

• Primary Device ID: 20887787006708
• NIH Device Record Key: 478c773b-de91-4432-9786-8f0cee7327a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irrigation Set
• Version Model Number: 654101
• Catalog Number: 0654101
• Company DUNS: 830767898
• Company Name: ICU MEDICAL FLEET SERVICES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com

Device Dimensions

• Length: 26 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature. Avoid Excessive Heat. Protect from Freezing

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887787006701 [Primary]
GS1	20887787006708 [Package]; Contains: 10887787006701; Package: case [20 Units]; In Commercial Distribution
HIBCC	M3356541010 [Secondary]

FDA Product Code

• GBX: CATHETER, IRRIGATION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-30
• Device Publish Date: 2018-06-28

On-Brand Devices [Irrigation Set]

• 20887787007248: LATEX-FREE 4-LEAD T-U-R IRRIGATION SET Nonvented Set for Transurethral Resection Procedures 85 i
• 20887787006746: LATEX-FREE LARGE BORE Y-IRRIGATION SET Nonvented Set 100 Inch (254 cm) For Flexible Irrigation C
• 20887787006739: LATEX-FREE CYSTOSCOPY/IRRIGATION SET Nonvented, 77 inch (195 cm) for Constant or Intermittent Bl
• 20887787006708: LATEX-FREE SECONDARY IRRIGATION SET For Series Hookup For Use with Flexible Container Irrigation
• 20887787006692: LATEX-FREE CATHETER IRRIGATION SET, Convertible Pin, 70 Inch (previously Hospira product)