AccessGUDID - DEVICE: HarmonyAIR (10724995150119)

GUDID

Device Identifier (DI) Information

Brand Name: HarmonyAIR
Version or Model: Smoke Evacuator Filter Fluid Trap
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: QS0027
Company Name: STERIS CORPORATION

Primary DI Number: 10724995150119
Issuing Agency: GS1
Commercial Distribution End Date: December 22, 2020
Device Count: 10
Labeler D-U-N-S® Number*: 036985604 *Terms of Use

Device Description: The HarmonyAIR Smoke Evacuator Filter Fluid Traps is a box of 10 filter fluid traps for the HarmonyAIR Smoke Evacuator that is designed to capture fluids to help maintain the integrity of the filtration system and assist with maintaining filter life.

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?
34858	Surgical suction system collection container, single-use	A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. 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: No
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: 84810f36-ad9c-4e34-b63c-4277cc76cd10
Public Version Date: November 28, 2022
Public Version Number: 11
DI Record Publish Date: September 06, 2016