Cannula, Nasal, Oxygen

Device Code: 91

Product Code(s): CAT

Device Classification Information

• Device Type ID: 91
• Device Name: Cannula, Nasal, Oxygen
• Regulation Description: Nasal Oxygen Cannula.
• 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) Exempt
• CFR Regulation Number: 868.5340 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: CAT
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

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: 91
• Device: Cannula, Nasal, Oxygen
• Product Code: CAT
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Nasal Oxygen Cannula.
• CFR Regulation Number: 868.5340 [🔎]

Device Problems
Device Issue	87
Device Handling Problem	58
Disconnection	36
Kinked	36
Split	34
Hole In Material	31
Leak / Splash	22
Detachment Of Device Or Device Component	19
Break	15
Detachment Of Device Component	15
Improper Flow Or Infusion	13
Folded	12
Torn Material	10
Device Sensing Problem	10
Use Of Device Problem	10
Improper Or Incorrect Procedure Or Method	9
Material Separation	9
Bent	8
Connection Problem	8
Adverse Event Without Identified Device Or Use Problem	8
No Flow	6
Material Split, Cut Or Torn	5
Misassembled	4
Complete Blockage	4
Defective Device	3
Unraveled Material	3
Material Integrity Problem	3
Fire	2
Device Operates Differently Than Expected	2
Gas Leak	2
Infusion Or Flow Problem	2
Occlusion Within Device	2
No Apparent Adverse Event	2
Physical Property Issue	2
Failure To Deliver	2
Device Damaged Prior To Use	2
Material Opacification	2
Knotted	2
Device Contamination With Chemical Or Other Material	2
Material Deformation	2
Partial Blockage	2
Pressure Problem	1
Fitting Problem	1
Off-Label Use	1
Tube	1
Air Leak	1
Material Protrusion / Extrusion	1
Loose Or Intermittent Connection	1
Material Rupture	1
Restricted Flow Rate	1
Blocked Connection	1
Crack	1
Cut In Material	1
Insufficient Information	1
Obstruction Of Flow	1
Therapeutic Or Diagnostic Output Failure	1
Appropriate Term/Code Not Available	1
Cannula	1
Material Twisted / Bent	1
Fracture	1
Inaccurate Flow Rate	1
Total Device Problems	526

Recalls
Manufacturer		Recall Class	Date Posted
1	Smiths Medical ASD Inc.	III	Oct-05-2018
2	Teleflex Medical	II	Jun-07-2017

TPLC Last Update: 2019-04-02 19:28:46