Enteer ENB-375-20-135

GUDID 00821684052747

Re-entry Catheter

Covidien LP

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00821684052747
• NIH Device Record Key: e287687f-1e18-4806-9a63-4eaa1090e987
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enteer
• Version Model Number: ENB-375-20-135
• Catalog Number: ENB-375-20-135
• Company DUNS: 968903703
• Company Name: Covidien LP
• 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: 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Outer Diameter: 3.75 Millimeter
• Length: 20 Millimeter
• Catheter Gauge: 5 French
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684052747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120533

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2015-10-09

On-Brand Devices [Enteer]

• 00821684052778: Guidewire;Stiff
• 00821684052761: Guidewire;Standard
• 00821684052754: Guidewire;Flexible
• 00821684052747: Re-entry Catheter
• 00821684052730: Re-entry Catheter