FDA.reportPublic FDA data

KYCARE

Primary DI
06978651650766
Brand
KYCARE
Company
Foshan KYCARE Medical Equipment Co., Ltd.
Model
FRPA6V-0
Catalog number
CAX
Device description
The fire stop valve (model: FRPA6V-0) is a hot melt ball valve designed to extinguish oxygen delivery tube fire by stopping the flow of oxygen, in the event the nasal cannula or oxygen tube is accidentally ignited and the fire potentially burns back or toward to reach the device or the patient. It is bidirectional in operation and can be installed either way around in the oxygen delivery tubing. The fire stop alve is a risk control measure to low flow, low pressure oxygen delivery circuit for patients requiring supplemental oxygen at home or healthcare facility. It is a non-sterile, single patient and multiple use device.
Published
2026-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAXFlowmeter, Tube, Thorpe, Back-Pressure CompensatedAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06978651650766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978651650766069786516507666978651650766

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen tubing fire safety valveA safety device intended to be integrated into oxygen delivery tubing to automatically stop the flow of oxygen and isolate the oxygen supply in the event of a fire. It typically consists of a small two-way tubing connector containing a thermal fuse. This is a single-patient, reusable device.

Regulatory Flags#

DUNS number
976062605
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934726614514Firebreaker valveLongfian Scitech Co., Ltd.CAX2026-04-25
00628101608187OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608194OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608200OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608217OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608224OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608231OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608248OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608255OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608262OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608279OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608286OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608293OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608309OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608316OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608323OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608330OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608347OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608354OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608361OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608378OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608385OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608392OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608408OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608415OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608422OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608439OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608446OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608453OhioOHIO MEDICAL, LLCCAX2026-04-15
00628101608460OhioOHIO MEDICAL, LLCCAX2026-04-15