Pipeline FA-77250-10

GUDID 00836462014084

Embolization Device

Covidien LP

Bare-metal intracranial vascular stent

Primary Device ID	00836462014084
NIH Device Record Key	444864fe-1316-4287-8dad-c1fd927ad973
Commercial Distribution Status	In Commercial Distribution
Brand Name	Pipeline
Version Model Number	FA-77250-10
Catalog Number	FA-77250-10
Company DUNS	058614483
Company Name	Covidien LP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
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	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com

Device Dimensions

Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter
Length	10 Millimeter
Device Size Text, specify	0
Outer Diameter	2.5 Millimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Special Storage Condition, Specify	Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462014084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P100018

FDA Product Code

OUT	Intracranial aneurysm flow diverter

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	2018-07-06
Device Publish Date	2014-09-22

Devices Manufactured by Covidien LP

10884521856127 - Vital Sync	2025-09-09 VITAL SYNC V3 SOFTWARE
10884521856134 - Vital Sync	2025-08-26 VITAL SYNC V4 SOFTWARE
20884521854144 - DAR	2025-08-18 L Connector Double Swivel
10884521825666 - McGRATH	2025-08-11 Rechargeable Battery;For McGRATH (TM) MAC Video Laryngoscope
20884521855370 - Valleylab SM	2025-07-18 Smoke Management Pencil Adapter
10884521845985 - INVOS	2025-07-11 INVOS(TM) rSO2 micro-module;For use with GE HealthCare Patient Monitors
20884521829005 - DAR	2025-07-04 Adult Electrostatic Filter HME Large
20884521829104 - DAR	2025-07-04 Pediatric Electrostatic Filter HME Small

Trademark Results [Pipeline]

Mark Image Registration \| Serial	Company Trademark Application Date
PIPELINE 98427175 not registered Live/Pending	Trailer Wheel & Frame Co. 2024-02-29
PIPELINE 98138748 not registered Live/Pending	INDEPENDENT FACILITIES SERVICES CORP 2023-08-18
PIPELINE 98109732 not registered Live/Pending	INDEPENDENT FACILITIES SERVICES CORP 2023-07-31
PIPELINE 97899775 not registered Live/Pending	Association of Surfing Professionals LLC 2023-04-20
PIPELINE 97636173 not registered Live/Pending	Sea World LLC 2022-10-18
PIPELINE 97232000 not registered Live/Pending	Neuro AI Inc. 2022-01-21
PIPELINE 90845915 not registered Live/Pending	BLACK HILLS IP HOLDINGS, LLC 2021-07-23
PIPELINE 90716219 not registered Live/Pending	Pipeline Equity, Inc. 2021-05-17
PIPELINE 88613586 not registered Live/Pending	Upload, LLC 2019-09-11
PIPELINE 88613552 not registered Live/Pending	Upload, LLC 2019-09-11
PIPELINE 88472742 not registered Live/Pending	PureEdge Lighting 2019-06-13
PIPELINE 87653081 5501415 Live/Registered	MARTINETTI, DOMINICK 2017-10-20