Ethox Medical

GUDID 20889483150044

Gastric Lavage Kit with 32fr Tubes and (2) 25g Activated Charcoal with Aqua

ETHOX MEDICAL, LLC

Gastric lavage kit

• Primary Device ID: 20889483150044
• NIH Device Record Key: e7e9d73c-4ddf-4c15-bb48-e65ba2799fdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ethox Medical
• Version Model Number: 950095603
• Company DUNS: 079149179
• Company Name: ETHOX MEDICAL, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-433-2797
• Email: info@sun-med.com
• Phone: 800-433-2797
• Email: info@sun-med.com

Device Dimensions

• Catheter Gauge: 32 French
• Catheter Gauge: 32 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *General Warehouse. Do not get wet.
• Special Storage Condition, Specify: Between 0 and 0 *General Warehouse. Do not get wet.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889483150047 [Primary]
GS1	20889483150044 [Package]; Contains: 10889483150047; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962850

FDA Product Code

• KDH: Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-29

On-Brand Devices [Ethox Medical]

• 20889483150167: Gastric Lavage Kit with Spike, (2) 25g Activated Charcoal with Sorbitol
• 20889483150075: Gastric Lavage Kit with 32fr Lavage Tubes & 3L Bag
• 20889483150068: Gastric Lavage Kit with 32fr Tubes and (1) 25g Activated Charcoal and (1) 25g Activated Charcoal
• 20889483150051: Gastric Lavage Kit with 32fr Tubes and (2) Activated Charcoal with Sorbitol
• 20889483150044: Gastric Lavage Kit with 32fr Tubes and (2) 25g Activated Charcoal with Aqua
• 20889483150037: Bite Block
• 10889483149782: 28fr Lavage Tubes
• 20889483131142: 36fr Lavage Tubes
• 20889483131135: 24fr Lavage Tubes
• 20889483131098: Gastric Lavage Kit with 3L Bag
• 20889483130961: 32fr Lavage Tubes
• 20889483130954: Gastric Lavage Kit with Spike, No Solution Bag