IV Extension Set 6" DU2260

GUDID 10850014433137

are connected to IV catheters to allow a larger distance between the patient and the fluid being administered which is often necessary due to the size and volume of equipment being used at any one time

DISTRIBUTION UNLIMITED, LLC

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Primary Device ID	10850014433137
NIH Device Record Key	a6c645a9-1c53-4132-89ec-8580f3a18bd5
Commercial Distribution Status	In Commercial Distribution
Brand Name	IV Extension Set 6"
Version Model Number	1
Catalog Number	DU2260
Company DUNS	926603486
Company Name	DISTRIBUTION UNLIMITED, 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	false
OTC Over-The-Counter	false

Device Dimensions

Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
Device Size Text, specify	0
Length	6 Inch
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Length	6 Inch
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00850014433130 [Primary]
GS1	10850014433137 [Package] Contains: 00850014433130 Package: Case [100 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151151

FDA Product Code

FPA	Set, Administration, Intravascular

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-08-27
Device Publish Date	2020-08-19

Devices Manufactured by DISTRIBUTION UNLIMITED, LLC

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