TPLC - Total Product Life Cycle

• Device: valve, non-rebreathing
• Product Code: CBP
• Regulation Number: 868.5870
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
12TH MAN TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BPR MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
FIRSTAR HEALTHCARE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FIRSTAR HEALTHCARE COMPANY LIMITED (GUANGZHOU)
	SUBSTANTIALLY EQUIVALENT	1
FISHER & PAYKEL HEALTHCARE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FISHER & PAYKEL HEALTHCARE LTD
	SUBSTANTIALLY EQUIVALENT	1
GENUINE FIRST AID LLC
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU JINLIN MEDICAL APPLIANCES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTERSURGICAL INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
MEDITERA TIBBI MALZEME SAN VE TIC AS
	SUBSTANTIALLY EQUIVALENT	1
THE LIFEGUARD STORE, INC.
	SUBSTANTIALLY EQUIVALENT	1
WET NOSE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
XIAMEN COMPOWER MEDICAL TECH. CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	11	11
2017	1	1
2019	1	1
2021	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Operates Differently Than Expected	6	6
Physical Resistance	4	4
Detachment Of Device Component	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Detachment of Device or Device Component	1	1
Labelling, Instructions for Use or Training Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	7	7
No Patient Involvement	2	2
No Consequences Or Impact To Patient	2	2
No Clinical Signs, Symptoms or Conditions	1	1
Test Result	1	1
No Information	1	1
Foreign Body In Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Dynarex Corporation	II	Jul-25-2014
2	Lifeline First Aid LLC	II	Jul-06-2016