NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207048566
• Version / Model: 4170503
• Catalog Number: 4170503
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-06-28
• Public Version: 5
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 8bfae8b3-2d83-4533-974b-ad049c0d3054

Device Description

SMOKE ASPIRATION TUBE SET L 2.7M PVC, PACK=10 PCS, for insufflators 45 2235011, 2235031, 2235611 and 2235631, sterile, for single use

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: 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
NKC	Tubing/tubing with filter, insufflation, laparoscopic	Obstetrics/Gynecology	884.1730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31723	Suction system filter, plume particulate	A screening device installed within the suction tubing line of a suction system, or the suction tubing used with a central vacuum system, to extract particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent clogging of the suction or vacuum system. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs and can be made of translucent plastic, allowing for inspection when in use. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207048566	GS1
Unit of Use	04055207049990	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	2.7	Meter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 70 Percent (%) Relative Humidity