FDA.reportPublic FDA data

Breathing Circuit

Primary DI
00848530108892
Brand
Breathing Circuit
Company
Sunset Healthcare Solutions, Inc.
Model
VC1002P-R
Device description
Sunset Pediatric Active Circuit, Heated, ResMed
Published
2026-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201418000Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.2021-01-29BZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530108899PackageGS130In Commercial Distribution
00848530108892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853010889910848530108899
00848530108892008485301088928485301088920848530108892

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530108885Breathing CircuitVC1002-R2026-10-12
00848530109882CPAP FilterCF2111HA-10PL2026-09-30
00848530109899CPAP FilterCF2107HA-10PL2026-09-30
00848530109905Oxygen KitRESO2KITAZPL2026-09-30
00848530109912Nebulizer and CompressorACTNEB1002026-09-30
00848530109141Oxygen, Bacteria & HEPA FilterOF11003BR2026-06-30
00848530109165Oxygen, Bacteria & HEPA FilterOF11005BR2026-06-30
00848530109295Oxygen kitAATH006O2KIT2026-06-11
00848530109462Nasal CPAP MaskCM060-KITLNV2026-07-15
00848530109479Nasal CPAP MaskCM060L-NV2026-07-15
00848530109486Nasal CPAP MaskCM060XL-NV2026-07-15
00848530109523Oxygen KitAHOW001O2KIT2026-08-20
00848530109592Ventilator FilterVF010-12026-08-20
00848530109608Ventilator FilterVF010F-12026-08-20
00848530109639Nasal CPAP MaskCM060SNH2026-08-24
00848530109646Nasal CPAP MaskCM060MNH2026-08-24
00848530109653CPAP MaskCM061SNH2026-08-24
00848530109660CPAP MaskCM061MNH2026-08-24
00848530109691CPAP HeadgearHG060B2026-09-09
00848530109721OXYGEN CONNECTOR/ADAPTERRES019-1PL2026-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530108885Breathing CircuitSunset Healthcare Solutions, Inc.BZE2026-10-12
00819989012399S10 Heated CPAP TubeEXCELERON MEDICAL, INC.BZE2026-10-05
10197344039418HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043064HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043071HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043101HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043118HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344176434HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176441HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176458HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176465HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344011629HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-01-21
10889483617007AirLife™AIRLIFEBZE2025-02-27
09420012448422Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
09420012453204Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
09420012459213Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
10197344043040HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043057HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043088HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043095HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
00848530104153Passive Heated Breathing Circuit KitSunset Healthcare Solutions, Inc.BZE2024-05-30
00848530070670Heated CPAP Tube for DreamStation Series and PR System OneSunset Healthcare Solutions, Inc.BZE2024-03-05
00848530102753Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.BZE2024-02-20
04048675389583VentStar humidifier chamber (N)Drägerwerk AG & Co. KGaABZE2023-07-21
04048675411758VentStar Helix heated (N) PlusDrägerwerk AG & Co. KGaABZE2023-07-21
04048675414520Double connector 11ID/15OD 20xDrägerwerk AG & Co. KGaABZE2023-07-21
04048675742739VentStar Helix dual heated N Exten. KitDrägerwerk AG & Co. KGaABZE2023-07-21
09420012431080Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012431165Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012432162Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02