FDA.report

NA

Primary DI
40845854061887
Brand
NA
Company
Conmed Corporation
Model
QS0026
Catalog number
QS0026
Device description
HarmonyAIR Smoke Evacuator Tubing
Published
2021-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GAZTUBING, NONINVASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40845854061887PackageGS112In Commercial Distribution
20845854061883PreviousGS10
10845854061886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4084585406188740845854061887
2084585406188320845854061883
1084585406188610845854061886

GMDN Terms

TermDefinition
Surgical plume evacuation system tubeA sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume 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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags

DUNS number
071595540
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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