Primary Sets B920101

GUDID 20887787009280

PRIMARY SET 2 CLAVE Y-Sites, 100 Inch, Non-DEHP

ICU MEDICAL FLEET SERVICES, LLC

Intravenous administration set Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive

• Primary Device ID: 20887787009280
• NIH Device Record Key: b5a4f674-e1f5-46af-9d9a-aee1095a4836
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primary Sets
• Version Model Number: B920101
• Catalog Number: B920101
• 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
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 100 Inch
• Device Size Text, specify: 0

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
• 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	10887787009283 [Primary]
GS1	20887787009280 [Package]; Contains: 10887787009283; Package: Corrugated Box [25 Units]; In Commercial Distribution
HIBCC	M335B9201010 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142367

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-11
• Device Publish Date: 2018-06-04

On-Brand Devices [Primary Sets]

• 20887787009303: PRIMARY SET 3 CLAVE Y-Sites, 100 Inch, Non-DEHP
• 20887787009297: Primary MICRODRIP Set 2 CLAVE Y-Sites, 100 Inch, Non-DEHP
• 20887787009280: PRIMARY SET 2 CLAVE Y-Sites, 100 Inch, Non-DEHP
• 20887787009273: PRIMARY SET CLAVE Y-Site, 100 Inch, Non-DEHP