Insuflow 6198

GUDID 00852588007007

Laparoscopic gas conditioning device.

LEXION MEDICAL, LLC

Insufflation gas conditioning tubing set

• Primary Device ID: 00852588007007
• NIH Device Record Key: 4f3a60c6-f3c7-4e2c-8228-c95bfa0e1ad8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insuflow
• Version Model Number: 6198
• Catalog Number: 6198
• Company DUNS: 848693730
• Company Name: LEXION 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: 6516350000
• Email: customerservice@lexionmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852588007007 [Primary]

FDA Product Code

• HIF: Insufflator, Laparoscopic

Sterilization

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

[00852588007007]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-26

On-Brand Devices [Insuflow]

• 00852588007038: LAPAROSCOPIC GAS CONDITIONING DEVICE
• 00852588007021: LAPAROSCOPIC GAS CONDITIONING DEVICE
• 00852588007014: Laparoscopic gas conditioning device
• 00852588007007: Laparoscopic gas conditioning device.