TEMED

GUDID 05060660970025

TEMED Gas Diffuser A device designed for controlled diffusion of a medical gas [e.g., carbon dioxide (CO2), humidified air] into an open surgical wound during an open surgical gas insufflation procedure, typically to minimize the risk of air embolism or reduce heat transfer from the surgical wound. The diffuser typically includes connection tubing and may also include a filter. This is a single-use device.

Temed

Surgical wound gas diffuser

• Primary Device ID: 05060660970025
• NIH Device Record Key: 6d7b1de2-23a3-4e3d-8d5d-0fbd017f35a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEMED
• Version Model Number: P2514
• Company DUNS: 215842226
• Company Name: Temed
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com
• Phone: +441243572255
• Email: sales@temedmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060660970025 [Primary]
GS1	05060660971732 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173545

FDA Product Code

• HIF: Insufflator, Laparoscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-01
• Device Publish Date: 2023-04-21

On-Brand Devices [TEMED]

• 05060660970025: TEMED Gas Diffuser A device designed for controlled diffusion of a medical gas [e.g., carbon dio
• 05060660971749: TEMED Mini Sucker Line The TEMED Suckers are single use, sterile devices that are intended for t
• 05060660971503: TEMED Sucker Line The TEMED Suckers are single use, sterile devices that are intended for the ex