Sapphire 1638802

GUDID 20887787007477

SAPPHIRE Primary Set 119 Inch (previously Hospira product)

ICU MEDICAL FLEET SERVICES, LLC

Electric infusion pump administration set, single-use

• Primary Device ID: 20887787007477
• NIH Device Record Key: db75e6db-d625-4f05-9de3-8022a4fec663
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire
• Version Model Number: 1638802
• Catalog Number: 1638802
• Company DUNS: 830767898
• Company Name: ICU MEDICAL FLEET SERVICES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 119 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	10887787007470 [Primary]
GS1	20887787007477 [Package]; Contains: 10887787007470; Package: Corrugated Box [40 Units]; In Commercial Distribution
HIBCC	M33516388021 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171346

FDA Product Code

• MRZ: ACCESSORIES, PUMP, INFUSION

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-06-04

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