FDA.reportPublic FDA data

CPAP Tubing

Primary DI
00812028033232
Brand
CPAP Tubing
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
ALIN005TUB06
Device description
CPAP Supply USA Private Labeled Sunset Healthcare 6Ft Gray Smoothbore CPAP Tubing
Published
2024-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812028033232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812028033232008120280332328120280332320812028033232

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory/expiratory limb respiratory tubing, reusableA length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530109127Oxygen, Bacteria & HEPA FilterOF1001BR2026-06-23
00848530109134Oxygen, Bacteria & HEPA FilterOF1005BR2026-06-23
00848530109172Oxygen, Bacteria & HEPA FilterOF11006BR2026-06-23
00848530109189Oxygen, Bacteria & HEPA FilterOF3002BR2026-06-23
00848530109196Oxygen, Bacteria & HEPA FilterOF5001BR2026-06-23
00848530109202Oxygen, Bacteria & HEPA FilterOF6001BR2026-06-23
00848530109219Oxygen, Bacteria & HEPA FilterOF8002BR2026-06-23
00848530109226Oxygen, Bacteria & HEPA FilterOF9001BR2026-06-23
00848530109233Oxygen, Bacteria & HEPA FilterOF9002BR2026-06-23
00848530109240Oxygen, Bacteria & HEPA FilterOF9004BR2026-06-23
00848530109257Oxygen, Bacteria & HEPA FilterBF2200BR2026-06-23
00848530109110Suction KitRES026S-KITC2026-06-10
00848530107451Stratus Power SwitchRP0762025-09-24
00848530107468Stratus Pneumatic ValveRP0772025-09-24
00848530108984CPAP MaskCM206SNH2026-06-04
00848530108991CPAP MaskCM206MNH2026-06-04
00848530109004CPAP MaskCM206LNH2026-06-04
00848530109042CPAP MaskCM207SNH2026-06-04
00848530109059CPAP MaskCM207MNH2026-06-04
00848530109066CPAP MaskCM207LNH2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E496C05ADPTPDH0LUER LOCK Adaptor for pneumodissectorAB MEDICABYX2026-07-08
00607411919268Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-10
00607411919282Oxygen Tubing Swivel ConnectorSALTER LABSBYX2026-06-10
00607411919220Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919237Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919244Salter Labs® Oxygen TubingSALTER LABSBYX2026-06-09
00607411919251Salter Labs® Oxygen Tubing (MedTronic)SALTER LABSBYX2026-06-09
B929C4NI024FNNFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4AIK240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
B929N4OXW240FHTFP40Western Enterprises, IncWestern EnterprisesBYX2026-06-04
00848530108328Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-03
00848530108953Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530108960Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530108977Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109011Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109028Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109035Repair PartSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
00848530109073Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-06-02
10197344011230HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-13
10197344011155HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-12
10197344042401HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-02-12
10885632467431HalyardOWENS & MINOR DISTRIBUTION, INC.BYX2026-01-29
10889483234402curaplex®SUNMED, LLCBYX2025-12-31
10889483225639AirLife™SUNMED, LLCBYX2025-12-18
10889483229279AirLife™SUNMED, LLCBYX2025-12-18
10197344162710MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
10197344162727MEDLINEMEDLINE INDUSTRIES, INC.BYX2025-12-12
10197344011780HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012237HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03
10197344012244HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2025-12-03