- Physicians Office Resource

Bile Bag
Davol Bile Bag, Small - 0015860

Device Description

A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

Total Volume: 9 Fluid Ounce

Length: 8 Inch

Total Volume: 9 Fluid Ounce
Length: 8 Inch

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: FGE

Device Name: Stents, Drains And Dilators For The Biliary Ducts

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 876.5010

Third Party Flag: N

Medical Specialty: GU

Code: EXF

Device Name: Bag, Bile Collecting

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.5010

Third Party Flag: N

Medical Specialty: GU

Device Identifiers

Device Id: 10801741011624

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741011627

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA

Device Id: 00801741011627

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

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