N/A

Basic Information

• Brand Name: N/A
• Primary DI: 05030267052233
• Version / Model: 1344007S
• Company Name: Intersurgical Incorporated
• Labeler DUNS: 785952607
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-16
• Public Version: 2
• Public Version Date: 2022-02-07
• Public Version Status: Update
• Public Device Record Key: 31460980-40d9-4693-aa76-c46bfff5c924

Device Description

INTER-GUARD BREATHING FILTER - STERILE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• 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
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	868.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60839	Microbial medical gas filter, sterile, single-use	A sterile screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia, and/or surgical intervention (e.g., insufflation); it has no additional non-filtering intended uses. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05030267091249	GS1		50	In Commercial Distribution
Primary	05030267052233	GS1

Customer Contacts

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