FDA.reportPublic FDA data

Ventilator Circuit

Primary DI
00848530106317
Brand
Ventilator Circuit
Company
Sunset Healthcare Solutions, Inc.
Model
VC1114P
Device description
Pediatric Passive Heated Breathing Circuit for use with MR850 Humidifier
Published
2025-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZAConnector, Airway (Extension)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530106317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530106317008485301063178485301063170848530106317

GMDN Terms#

Term, Definition table
TermDefinition
Artificial airway cuff inflation tubingA length of flexible tube designed to connect cuff inflation devices to deliver air during inflation of the cuff of an endotracheal (ET)/ tracheostomy tube. It typically includes connectors at each end. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

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
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
00848530109738CPAP FilterCF1015NS2026-08-31
00848530109783Oxygen AccessoryPOCBAG-P22026-09-09
00848530109813AerosolTUB100-1FT15MM2026-09-09
00848530109820Ventilation AccessoryVEN008NS2026-09-09
00848530109837Ventilation AccessoryRES096MPNS2026-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109721OXYGEN CONNECTOR/ADAPTERSunset Healthcare Solutions, Inc.BZA2026-09-09
00848530109820Ventilation AccessorySunset Healthcare Solutions, Inc.BZA2026-09-09
00848530109837Ventilation AccessorySunset Healthcare Solutions, Inc.BZA2026-09-09
06923980103629N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
06923980107672N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
06923980111969N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
04719874957551Create BiotechCREATE BIOTECH CO., LTD.BZA2026-07-21
04719874959197Create BiotechCREATE BIOTECH CO., LTD.BZA2026-07-21
05055931133858Reusable Angle Connector for CBS Bag Arm – Male to MaleFLEXICARE MEDICAL LIMITEDBZA2026-07-21
05055931133865Reusable Angle Connector for CBS Bag Arm – Male to FemaleFLEXICARE MEDICAL LIMITEDBZA2026-07-21
10197344012039HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-07-06
10197344214792HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-05-18
10197344009800HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
10197344012008HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012435HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012466HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012596HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344042326HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10889483225257AirLife™SUNMED, LLCBZA2025-12-22
10889483225226Adapters/ConnectorsSUNMED, LLCBZA2025-12-18
10197344012473HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-12-12
00848530107925Tracheostomy and SuctionSunset Healthcare Solutions, Inc.BZA2025-12-09
00848530098261VENTILATOR ACCESSORYSunset Healthcare Solutions, Inc.BZA2025-08-28
00848530107246Oxygen Connector/AdapterSunset Healthcare Solutions, Inc.BZA2025-08-19
10197344042432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-08-18
10884521854147DARCovidien LPBZA2025-08-10
00848530106324Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530106331Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530106348Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530060299Oxygen Connector/AdapterSunset Healthcare Solutions, Inc.BZA2025-06-03