Nebulizer (direct Patient Interface)

Device Code: 83

Product Code(s): CAF

Device Classification Information

Device Type ID	83
Device Name	Nebulizer (direct Patient Interface)
Regulation Description	Nebulizer.
Regulation Medical Specialty	Anesthesiology
Review Panel	Anesthesiology
Premarket Review	Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB)
Submission Type	510(k)
CFR Regulation Number	868.5630 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	CAF
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Program

Recognized Standards

1-134 ISO 18562-1 First Edition 2017-03
Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 1: Evaluation And Testing Within A Risk Management Process
1-135 ISO 18562-2 First Edition 2017-03
Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 2: Tests For Emissions Of Particulate Matter
1-136 ISO 18562-3 First Edition 2017-03
Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 3: Tests For Emissions Of Volatile Organic Compounds
1-137 ISO 18562-4 First Edition 2017-03
Biocompatibility Evaluation Of Breathing Gas Pathways In Healthcare Applications - Part 4: Tests For Leachables In Condensate

Total Product Life Cycle

Device Type ID	83
Device	Nebulizer (direct Patient Interface)
Product Code	CAF
FDA Device Classification	Class 2 Medical Device
Regulation Description	Nebulizer.
CFR Regulation Number	868.5630 [🔎]

Premarket Reviews
Manufacturer	Decision
ADHERIUM (NZ) LTD
	SUBSTANTIALLY EQUIVALENT	4
AEROGEN LTD.
	SUBSTANTIALLY EQUIVALENT	1
BESMED HEALTH BUSINESS CORP.
	SUBSTANTIALLY EQUIVALENT	1
CAREFUSION
	SUBSTANTIALLY EQUIVALENT	1
DIGIO2 INTERNATIONAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
INSTRUMENTATION INDU
	SUBSTANTIALLY EQUIVALENT	1
MEDIANATECHNOLOGIES CORP
	SUBSTANTIALLY EQUIVALENT	1
NEXUS6, LTD.
	SUBSTANTIALLY EQUIVALENT	1
OMRON HEALTHCARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
	SUBSTANTIALLY EQUIVALENT	1
PRE HOLDING, INC.
	SUBSTANTIALLY EQUIVALENT	1
RECIPROCAL LABS CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
SUZHOU WEIKANG MEDICAL APPARATUS CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
TELEFLEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
TRUDELL MEDICAL INT'L
	SUBSTANTIALLY EQUIVALENT	1
VECTURA GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Failure To Deliver	205
Connection Problem	106
Leak / Splash	100
Infusion Or Flow Problem	83
No Flow	55
Disconnection	44
Inaccurate Delivery	37
Fitting Problem	37
Electrical /Electronic Property Problem	25
Device Operates Differently Than Expected	18
Decrease In Pressure	14
Peeled / Delaminated	13
Degraded	13
Improper Flow Or Infusion	10
Detachment Of Device Or Device Component	9
Break	7
Fluid Leak	7
Gas Leak	7
Therapeutic Or Diagnostic Output Failure	6
Restricted Flow Rate	6
Cut In Material	5
Defective Device	5
Detachment Of Device Component	5
Overheating Of Device	4
Noise, Audible	4
Material Rupture	4
Component Missing	4
Fire	4
Improper Or Incorrect Procedure Or Method	4
Device Inoperable	3
Device Operational Issue	3
Use Of Device Problem	3
Loose Or Intermittent Connection	3
Air Leak	3
Failure To Power Up	2
Material Separation	2
Kinked	2
Device Damaged Prior To Use	2
Device Rinsing Issue	2
Temperature Problem	2
Insufficient Information	2
Mechanical Problem	2
Obstruction Of Flow	2
Maintenance Does Not Comply To Manufacturers Recommendations	2
Adverse Event Without Identified Device Or Use Problem	2
Insufficient Heating	2
Defective Component	2
Tear, Rip Or Hole In Device Packaging	1
Material Integrity Problem	1
Device Fell	1
Unstable	1
Human-Device Interface Problem	1
Sparking	1
Burst Container Or Vessel	1
Device Reprocessing Problem	1
Delivered As Unsterile Product	1
Occlusion Within Device	1
Chemical Problem	1
Material Frayed	1
Activation, Positioning Or Separation Problem	1
Crack	1
Delivery System Failure	1
Power Switch	1
Filtration Problem	1
Device Markings / Labelling Problem	1
Manufacturing, Packaging Or Shipping Problem	1
Moisture Or Humidity Problem	1
Complete Loss Of Power	1
Thermal Decomposition Of Device	1
Installation-Related Problem	1
Misassembly By Users	1
Device Handling Problem	1
Patient Device Interaction Problem	1
Hole In Material	1
Incorrect Device Or Component Shipped	1
No Pressure	1
Pressure Problem	1
Total Device Problems	912

Recalls
Manufacturer		Recall Class	Date Posted
1	Aerogen Ltd.	II	Oct-23-2014
2	Compass Health Brands	II	Jun-06-2015
3	Medex Cardio-Pulmonary Inc., D.b.a. Smiths Medical Company	I	Feb-04-2019
4	Nephron Pharmaceuticals Corp.	II	Jun-27-2016
5	Pharmacaribe Llc	II	Feb-10-2016
6	SANRAI INTERNATIONAL LLC	II	Mar-26-2019
7	Salter Labs	II	Feb-10-2016
8	Salter Labs	II	Sep-17-2015
9	Teleflex Medical	II	Dec-12-2014
10	Thayer Medical Corporation	II	Feb-07-2017
11	Valeant Pharmaceuticals North America LLC	II	Dec-04-2015
12	Valeant Pharmacueticals International	II	Jan-17-2018
13	Valeant Pharmacueticals International	II	Jan-21-2016

TPLC Last Update: 2019-04-02 19:28:02