- Physicians Office Resource

Endolumenal Functional Lumen Imaging Probe
EsoFLIP - ES-310

Device Description

A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.

Environmental Conditions

Handling Environment Atmospheric Pressure - KiloPascal

106.00
70.00

Handling Environment Humidity - Percent (%) Relative Humidity

95.00
15.00

Handling Environment Temperature - Degrees Celsius

40.00
20.00

Special Storage Condition, Specify

Fragile, Keep dry, This side up

Storage Environment Atmospheric Pressure - KiloPascal

106.00
50.00

Storage Environment Humidity - Percent (%) Relative Humidity

95.00
10.00

Storage Environment Temperature - Degrees Celsius

25.00
0.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: PIE

Device Name: Esophageal Dilator With Balloon And Electrode Sensors

Device Class: 2

Physical State: balloon with electrode sensors and software

Definition: To dilate esophageal strictures with a dilating balloon and electrode sensors.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: balloon with electrode sensors

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: esophagus

Regulation Number: 876.5980

Third Party Flag: N

Medical Specialty: GU

Device Identifiers

Device Id: 20884521809434

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521809437

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PACK_OR_INNER_PACK

Device Id: 10884521809437

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 30884521809431

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884521809434

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

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