FDA.reportPublic FDA data

Connector/Adapter

Primary DI
10848530087033
Brand
Connector/Adapter
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
VEN002
Device description
Swivel Exhalation Port for Ventilator Circuits & CPAP (Comparable to Respironics 332113)
Published
2024-08-02
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
false

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
00848530087036PrimaryGS10
10848530087033Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530087036008485300870368485300870360848530087036
1084853008703310848530087033

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
100
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
false
Expiration date on label
true
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
00848530108618CPAP FilterF-1382026-03-19
00848530108632CPAP TubingTUBE-962026-03-19
00848530108472Oxygen, Bacteria & HEPA FilterBF027-102026-03-17
00848530108489CPAP FilterA11FILTER12PK2026-03-17
10848530108646Repair PartsRP0972026-03-17
00848530108656Repair PartsRP0982026-03-17
10848530108660Repair PartsRP0992026-03-17
10848530108677Repair PartsRP1002026-03-17
10848530108684Repair PartsRP1042026-03-17
10848530108189Repair PartsRP1032026-03-09
10848530108196Repair PartsRP1052026-03-09
10848530108202Oxygen, Bacteria & HEPA FilterOF7003-102026-03-09
10848530108219Oxygen, Bacteria & HEPA FilterOF7005-102026-03-09
00848530108571Repair PartsRP101NS2026-03-09
00848530108588Repair PartsRP102NS2026-03-09
10848530108356Vented CPAP Masks VC10092026-03-03
10848530108363Vented CPAP Masks VC10102026-03-03
10848530108370Vented CPAP Masks VC10112026-03-03
10848530108387Vented CPAP Masks VC10122026-03-03
00848530108427Ventilator FilterVF005-12026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923980112799MindrayGaleMed Xiamen Co., Ltd.BZA2026-05-26
06944904007236MindrayGaleMed Xiamen Co., Ltd.BZA2026-05-26
16923980103206N/AGaleMed Xiamen Co., Ltd.BZA2026-05-25
20197344009807HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
44710810084858N/AGALEMED CORPORATIONBZA2026-03-05
44710810086548N/AGALEMED CORPORATIONBZA2026-03-05
44710810102453N/AGALEMED CORPORATIONBZA2026-03-05
44710810104037N/AGALEMED CORPORATIONBZA2026-03-05
44710810110731N/AGALEMED CORPORATIONBZA2026-03-05
44710810082601N/AGALEMED CORPORATIONBZA2026-03-04
44710810083929N/AGALEMED CORPORATIONBZA2026-03-04
44710810086753N/AGALEMED CORPORATIONBZA2026-03-04
44710810087187N/AGALEMED CORPORATIONBZA2026-03-04
44710810104563N/AGALEMED CORPORATIONBZA2026-03-04
44710810107328N/AGALEMED CORPORATIONBZA2026-03-04
44710810111417N/AGALEMED CORPORATIONBZA2026-03-04
44710810115941N/AGALEMED CORPORATIONBZA2026-03-04
00619498004409HumidAirRESMED PTY LTDBZA2026-02-09
04048675034643Connector M34X1.5, 9/16Drägerwerk AG & Co. KGaABZA2026-02-04
04048675034735Adapter 9/16" to 6mmDrägerwerk AG & Co. KGaABZA2026-02-04
20197344012005HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012463HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344012593HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
20197344042323HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
46923980107748N/AGaleMed Xiamen Co., Ltd.BZA2025-12-24
46923980107281N/AGaleMed Xiamen Co., Ltd.BZA2025-12-23
20889483225254AirLife™SUNMED, LLCBZA2025-12-22
20889483225223Adapters/ConnectorsSUNMED, LLCBZA2025-12-18
20889483225278AirLife™SUNMED, LLCBZA2025-12-18