Primary Sets B947301

GUDID 20887787009297

Primary MICRODRIP Set 2 CLAVE Y-Sites, 100 Inch, Non-DEHP

ICU MEDICAL FLEET SERVICES, LLC

Intravenous administration set

Primary Device ID	20887787009297
NIH Device Record Key	38df66fb-6fbf-401d-b3c2-58b350115d68
Commercial Distribution Status	In Commercial Distribution
Brand Name	Primary Sets
Version Model Number	B947301
Catalog Number	B947301
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
Length	100 Inch
Device Size Text, specify	0
Device Size Text, specify	0
Length	100 Inch
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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

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	10887787009290 [Primary]
GS1	20887787009297 [Package] Contains: 10887787009290 Package: Corrugated Box [50 Units] In Commercial Distribution
HIBCC	M335B9473010 [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