TEMED

Basic Information

• Brand Name: TEMED
• Primary DI: 05060660970025
• Version / Model: P2514
• Company Name: Temed
• Labeler DUNS: 215842226
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-21
• Public Version: 1
• Public Version Date: 2023-05-01
• Public Version Status: New
• Public Device Record Key: 6d7b1de2-23a3-4e3d-8d5d-0fbd017f35a6

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	884.1730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42977	Surgical wound 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060660970025	GS1
Package	05060660971732	GS1	Box	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173545	000