FDA.reportPublic FDA data

Breathing Circuit

Primary DI
00848530093204
Brand
Breathing Circuit
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
VC1114
Device description
Adult Single Limb Passive Heated Wire Circuit - Fisher & Paykel
Published
2024-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530093204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530093204008485300932048485300932040848530093204

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory gas heating wire, adultA non-sterile device intended to be integrated within a ventilator breathing circuit and used in conjunction with a heated respiratory humidifier (from which it draws its power) to maintain the temperature of inspiratory gasses during ventilation of an adult patient. It typically consists of a compact heating unit and a length of heated wire which is integrated within the lumen of an adult breathing circuit tube. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530108854Breathing CircuitVC1001-R2026-05-12
00848530108861Breathing CircuitVC1001P-R2026-05-12
00848530108878Breathing CircuitVEN004-R2026-05-12
00848530080136Comfort Shoulder Bag for D CylindersCSBDCSBD2018-07-31
00848530089214Carry Bag for Portable Suction MachineSU100DC-BAGSU100DC-BAG2018-05-25
00848530100452Nebulizer AccessoriesNEB300-BAG2024-07-30
00848530086503Personal Device HolderCSBML6M72024-06-28
00848530086992Personal Device HolderCSBML6-Hardshell2024-06-28
00848530080143Wheelchair/Scooter Carrier for E CylindersCSBECSBE2018-07-31
00848530080150Comfort Shoulder Bag for B/M6 CylindersCSBM6CSBM62018-07-31
00848530080167Backpack for B/M6, C/M9 or Smaller CylindersCSBM6BPCSBM6BP2018-07-31
00848530080174Comfort Shoulder Bag for C/M9 CylindersCSBM9CSBM92018-07-31
00848530081942Flex O2 BagCSBM6FlexCSBM6Flex2018-07-31
00848530087173Backpack for D CylindersCSBDBPCSBDBP2018-07-31
00848530087784Cylinder Roller Bag & Backpack — Single D/E TankCSBD1RollerCSBD1Roller2018-07-31
00848530087968Bag for Compressor NebulizerNEB100-BAGNEB100-BAG2018-05-29
00848530108939Ventilator FilterVF005-22026-04-30
00848530108946Ventilator FilterVF003-22026-04-30
00848530108809Ventilator accessoryVEN0072026-04-27
00848530108847CPAP FilterCF1012-2PLC2026-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645010048Standard Breathing Circuit with Face Mask - ToddlerMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010079Standard Breathing Circuit with MouthpieceMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010116Standard Breathing Circuit with Face Mask - Adult MediumMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010550Standard Breathing Circuit with TrachMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
H66860701051Mizzy Comfort CushionKeystone IndustriesCAI2022-11-30
H66860701151Mizzy Comfort CushionKeystone IndustriesCAI2022-11-30
10080196082070Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983599Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983933Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983940Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983971Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196984176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2021-11-03
10080196984343Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2021-11-03
10190752108806Vital Signs™AirLife Finland OyCAI2021-07-06
10190752108820Vital Signs™VYAIRE MEDICAL, INC.CAI2021-07-06
10190752118416Vital Signs™AIRLIFECAI2020-02-20
10190752118430Vital Signs™AIRLIFECAI2020-02-20
10190752118485Vital Signs™AIRLIFECAI2020-02-20
10190752118843Vital Signs™AIRLIFECAI2020-02-20
10190752118850Vital Signs™AIRLIFECAI2020-02-20
10190752118867Vital Signs™AIRLIFECAI2020-02-20
10190752118874Vital Signs™AIRLIFECAI2020-02-20
10190752118881Vital Signs™AIRLIFECAI2020-02-20
10190752118898Vital Signs™AIRLIFECAI2020-02-20
10190752118904Vital Signs™AIRLIFECAI2020-02-20
10190752118911Vital Signs™AIRLIFECAI2020-02-20
10190752118928Vital Signs™AIRLIFECAI2020-02-20
10190752118942Vital Signs™AIRLIFECAI2020-02-20
10190752118997Vital Signs™VYAIRE MEDICAL, INC.CAI2020-02-20