Primary Sets B912601

GUDID 20887787009303

PRIMARY SET 3 CLAVE Y-Sites, 100 Inch, Non-DEHP

ICU MEDICAL FLEET SERVICES, LLC

Intravenous administration set

• Primary Device ID: 20887787009303
• NIH Device Record Key: 218748dd-1fa5-4890-8a65-19294f9fff43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primary Sets
• Version Model Number: B912601
• Catalog Number: B912601
• 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

Device Dimensions

• Length: 100 Inch
• Length: 100 Inch
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887787009306 [Primary]
GS1	20887787009303 [Package]; Contains: 10887787009306; Package: Corrugated Box [50 Units]; In Commercial Distribution
HIBCC	M335B9126010 [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