AccessGUDID - DEVICE: HarmonyAIR (00724995150075)

GUDID

Device Identifier (DI) Information

Brand Name: HarmonyAIR
Version or Model: Smoke Evacuator Tubing
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: QS0023
Company Name: STERIS CORPORATION

Primary DI Number: 00724995150075
Issuing Agency: GS1
Commercial Distribution End Date: December 22, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The HarmonyAIR Sterile Smoke Evacuator Tubing, 7/8 inch x 6 Foot sterile tubing, is used for the HarmonyAIR Smoke Evacuator.

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):	No
Over the Counter (OTC):	Yes
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?
46483	Surgical plume evacuation system tube	A long, hollow cylinder which, as part of a surgical plume evacuation system, is intended to be used to capture, conduct, and exhaust the plume of smoke generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). 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
Length: 6 Feet

Device Record Status

Public Device Record Key: 0765ba82-f158-466d-8204-2f2a7d750c8a
Public Version Date: May 03, 2024
Public Version Number: 8
DI Record Publish Date: September 06, 2016