AccessGUDID - DEVICE: Nebulae Smoke Evacuation Tubing Set (00817183020639)

GUDID

Device Identifier (DI) Information

Brand Name: Nebulae Smoke Evacuation Tubing Set
Version or Model: 7-510-60
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NORTHGATE TECHNOLOGIES INC.

Primary DI Number: 00817183020639
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627969264 *Terms of Use

Device Description: This tubing set is used to evacuate surgical smoke using a wall vacuum source.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAZ	Tubing, Noninvasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c527acdf-cec8-46cb-8095-ed77c01d1558
Public Version Date: June 27, 2019
Public Version Number: 1
DI Record Publish Date: June 19, 2019