Sapphire 1639102

GUDID 20887787007514

SAPPHIRE Primary 1.2 Micron Filter Set CLAVE Y-Site, 121 Inch (previously Hospira product)

ICU MEDICAL FLEET SERVICES, LLC

Electric infusion pump administration set, single-use

• Primary Device ID: 20887787007514
• NIH Device Record Key: ded8bf6e-124b-4366-9bd9-33ceba6f85b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire
• Version Model Number: 1639102
• Catalog Number: 1639102
• 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
• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com
• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com
• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com
• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com
• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com
• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com
• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com
• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com
• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com
• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com
• Phone: +1(877)946-7747
• Email: uscustomercare@icumed.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 121 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 121 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 121 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 121 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 121 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 121 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 121 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 121 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 121 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 121 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 121 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887787007517 [Primary]
GS1	20887787007514 [Package]; Contains: 10887787007517; Package: Corrugated Box [50 Units]; In Commercial Distribution
HIBCC	M33516391020 [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

On-Brand Devices [Sapphire]

• 20887787009266: SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123
• 20887787009259: SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, 119 Inch
• 20887787009242: SAPPHIRE Epidural Set with NRFit Connector Non-Vented, Yellow-Striped Microbore, PAV, 118 Inch
• 20887787009235: SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 117 Inch
• 20887787007552: SAPPHIRE Y-Type Blood Set 200 Micron Blood Filter, 123 Inch (previously Hospira product)
• 20887787007538: SAPPHIRE Y-Type Blood Set 200 Micron Blood Filter, CLAVE Y-Site, 124 Inch (previously Hospira pr
• 20887787007521: SAPPHIRE Primary Polyethylene Lined Light Resistant Set Microbore, 121 Inch
• 20887787007514: SAPPHIRE Primary 1.2 Micron Filter Set CLAVE Y-Site, 121 Inch (previously Hospira product)
• 20887787007491: SAPPHIRE Primary Piggyback 0.2 Micron Filter Set MICRODRIP, Microbore, 2 CLAVE Y-Sites, 121 Inch
• 20887787007484: SAPPHIRE Primary Piggyback 0.2 Micron Filter Set 2 CLAVE Y-Sites, 121 Inch (previously Hospira p
• 20887787007477: SAPPHIRE Primary Set 119 Inch (previously Hospira product)
• 20887787007446: SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch (previously Hospira
• 20887787007439: SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch (previ
• 20887787007422: SAPPHIRE Primary Set Non-Vented, Microbore, PAV, 118 Inch (previously Hospira product)
• 20887787007415: SAPPHIRE Epidural Set Non-Vented, Yellow-Striped Microbore, PAV, 118 Inch (previously Hospira pr
• 20887787007408: SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch (previously Ho
• 20887787007392: SAPPHIRE Non-Vented PCA Set KVO Y-Extension, Microbore, PAV, 115 Inch (previously Hospira produc
• 20887787007361: SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, 119 Inch (previously Hospira
• 20887787007354: SAPPHIRE Primary 0.2 Micron Filter Set Microbore, CLAVE Y-Site, 118 Inch (previously Hospira pro
• 20887787007316: SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch (previously Hospira product)
• 20887787007309: SAPPHIRE Primary 0.2 Micron Filter Set CLAVE Y-Site, 112 Inch (previously Hospira product)
• 20887787007279: SAPPHIRE Primary 0.2 Micron Filter Set 115 Inch (previously Hospira product)
• 20887787007262: SAPPHIRE Primary 1.2 Micron Filter Set CLAVE Y-Site, 114 Inch (previously Hospira product)