FDA.reportPublic FDA data

HarmonyAIR

Primary DI
00724995150129
Brand
HarmonyAIR
Company
STERIS CORPORATION
Model
Smoke Evacuator Remote Switch Activator
Catalog number
QS0028
Device description
The HarmonyAIR Smoke Evacuator Remote Switch Activator (RSA) is used with the HarmonyAIR Smoke Evacuation System.
Published
2016-09-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYDAPPARATUS, EXHAUST, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131402000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131402000VISICLEAR SMOKE EVACUATION SYSTEMBuffalo Filter Co., Inc.2014-03-03FYD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995150129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995150129007249951501297249951501290724995150129

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation systemA mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
036985604
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995234232V. MuellerCD14BCD14B2026-08-26
00724995234249V. MuellerCD14BBLACKCD14BBLACK2026-08-26
00724995234256V. MuellerCD14BBLUECD14BBLUE2026-08-26
00724995234263V. MuellerCD14BGOLDCD14BGOLD2026-08-26
00724995234270V. MuellerCD14BGREENCD14BGREEN2026-08-26
00724995234287V. MuellerCD14BPURPLECD14BPURPLE2026-08-26
00724995234294V. MuellerCD14BREDCD14BRED2026-08-26
00724995234300V. MuellerCD14CCD14C2026-08-26
00724995234317V. MuellerCD14CBLACKCD14CBLACK2026-08-26
00724995234324V. MuellerCD14CBLUECD14CBLUE2026-08-26
00724995234331V. MuellerCD14CGOLDCD14CGOLD2026-08-26
00724995234348V. MuellerCD14CGREENCD14CGREEN2026-08-26
00724995234355V. MuellerCD14CPURPLECD14CPURPLE2026-08-26
00724995234362V. MuellerCD14CREDCD14CRED2026-08-26
00724995234379V. MuellerCD15BCD15B2026-08-26
00724995234386V. MuellerCD15BBLACKCD15BBLACK2026-08-26
00724995234393V. MuellerCD15BBLUECD15BBLUE2026-08-26
00724995234409V. MuellerCD15BGOLDCD15BGOLD2026-08-26
00724995234416V. MuellerCD15BGREENCD15BGREEN2026-08-26
00724995234423V. MuellerCD15BPURPLECD15BPURPLE2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840113242785BovieASPEN SURGICAL PRODUCTS, INC.FYD2026-09-18
10840113242792BovieASPEN SURGICAL PRODUCTS, INC.FYD2026-09-18
30845854655492PlumeSafe® X5™Conmed CorporationFYD2026-07-23
10705036046523MegadyneETHICON ENDO-SURGERY, LLCFYD2026-05-27
10860012888808Flamingo Funnel (miniSQUAIR) - LargeNASCENT SURGICAL, LLCFYD2026-05-01
10860012888815Flamingo Funnel (microSQUAIR) - MediumNASCENT SURGICAL, LLCFYD2026-05-01
10860012888822Flamingo Funnel (nanoSQUAIR) - Small NASCENT SURGICAL, LLCFYD2026-05-01
20845854081751CONMED BUFFALO FILTERConmed CorporationFYD2024-03-25
10193489085341MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
10193489085358MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
10845854600085Smoke Shark IIIConmed CorporationFYD2021-02-12
10845854600092Smoke Shark IIIConmed CorporationFYD2021-02-12
20845854600105Smoke Shark IIIConmed CorporationFYD2021-01-20
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10845854082898BOVIE SharkSkinConmed CorporationFYD2021-01-07
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