FDA.reportPublic FDA data

Breathing Circuit

Primary DI
00848530108854
Brand
Breathing Circuit
Company
Sunset Healthcare Solutions, Inc.
Model
VC1001-R
Device description
Sunset Adult Active Circuit, Non-Heated, ResMed
Published
2026-05-12
Public version status
Update
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
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530108851PackageGS150In Commercial Distribution
00848530108854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853010885110848530108851
00848530108854008485301088548485301088540848530108854

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
true
HCT/P
false
Kit
false
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530109875Ventilator accessoryVCMPV0012026-10-27
00848530110086Oxygen, Bacteria & HEPA FilterBF1412-32026-10-27
00848530093686Oxygen, Bacteria & HEPA FilterBF40002026-10-19
00848530109790Ventilator FilterVF015-12026-10-19
00848530109929Nebulizer and CompressorACTFISH2026-10-19
00848530109936Nebulizer and CompressorACTBEAR2026-10-19
00848530110031Ventilator FilterVF010-502026-10-19
00084853011017CPAP FilterCF1010F-502026-10-14
00848530109745CPAP FilterCF1015-42026-10-14
00848530109844CPAP FilterCF1015-6PL2026-10-14
00848530110024Oxygen KitADAPTO2SFTKIT2026-10-14
00848530110048Ventilator FilterVF010F-502026-10-14
00848530108885Breathing CircuitVC1002-R2026-10-12
00848530108892Breathing CircuitVC1002P-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109875Ventilator accessorySunset Healthcare Solutions, Inc.BZO2026-10-27
04055146499122Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499146Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499467Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499474Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499481Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499498Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499634Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055147001393Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055147001409Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146040935Breathing set, unheatedWILAmed GmbHBZO2026-10-19
04048675826088VentStar Coax GSL 180Drägerwerk AG & Co. KGaABZO2026-10-15
04048675826316Anesthesia Set Coax GSL 180Drägerwerk AG & Co. KGaABZO2026-10-15
05404013001507ClassicPlastiflex GroupBZO2026-09-21
05404013001521ClassicPlastiflex GroupBZO2026-09-21
00848530109813AerosolSunset Healthcare Solutions, Inc.BZO2026-09-09
14026704929204GIBECKTELEFLEX INCORPORATEDBZO2026-08-01
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