FDA.reportPublic FDA data

AeroEclipse* XL Breath Actuated Nebulizer

Primary DI
62860105513016
Brand
AeroEclipse* XL Breath Actuated Nebulizer
Company
Trudell Medical International
Model
105513
Catalog number
10551094006
Device description
AeroEclipse* XL BAN
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080926000AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZERTrudell Medical Intl.2008-08-12CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
62860105513016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6286010551301662860105513016

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system, non-heatedAn assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
519-455-4862customerservice@trudellmed.com

Regulatory Flags#

DUNS number
203298203
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00762860000582OMBRA* Table Top Compressor System 105510105510940062025-11-06
00762860055100OMBRA 120V Table Top Compressor System1055102020-03-25
62860105509026AEROECLIPSE BAN Replacement Mouthpiece Assembly105509105509940802020-03-24
62860105501020AEROECLIPSE II Breath Actuated Nebulizer Disposable105501105501940502016-09-24
62860105505028AEROECLIPSE II Breath Actuated Nebulizer Disposable with Elbow Adapter105505105505940502016-09-24
62860105506025AEROECLIPSE II Elbow Adapter for Breath Actuated Nebulizer Disposable105506105506940502016-09-24
62860105507022AEROECLIPSE XL Reusable Breath Actuated Nebulizer w AeroControl System Regulator105507105507940102016-09-24
62860105514020EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN105514105514940102016-09-30
62860105541026AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing105541105541940502016-09-24
62860105542023AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing105542105542940502016-09-24
00762860001138RESPICHAMBER* VHC with Mouthpiece1015332024-03-11
00762860055025REUSABLE COMFORTSEAL® Silicone Mask Assembly1055022024-03-11
00762860055032REUSABLE COMFORTSEAL® Silicone Mask Assembly1055032024-03-11
00762860055049REUSABLE COMFORTSEAL® Silicone Mask Assembly1055042024-03-11
10762860001135RESPICHAMBER* VHC with Mouthpiece1015332024-03-11
10762860055022REUSABLE COMFORTSEAL® Silicone Mask Assembly1055022024-03-11
10762860055039REUSABLE COMFORTSEAL® Silicone Mask Assembly1055032024-03-11
10762860055046REUSABLE COMFORTSEAL® Silicone Mask Assembly1055042024-03-11
00762860000827AEROCHAMBER* MV Holding Chamber825918251100502023-12-01
00762860125018RespiConnect* Adapter112501112501940402020-02-19

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