FDA.reportPublic FDA data

CPAP Tubing

Primary DI
00848530085407
Brand
CPAP Tubing
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
APAR008CAP1013
Device description
CPAP Tube Cleaning Brush – 6 feet
Published
2024-06-19
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
EPEBrush, Cleaning, Tracheal Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPEBrush, Cleaning, Tracheal TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530085407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530085407008485300854078485300854070848530085407

GMDN Terms#

Term, Definition table
TermDefinition
Airway device cleaning utensil, noninvasive, reusableA hand-held device intended to be used to clean an ex situ non-endoscopic airway device [e.g., endotracheal (ET) tube, tracheoesophageal speech valve, laryngeal airway], once it has been removed from the patient, to remove organic matter (e.g., phlegm). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device.

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
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
00848530109080CPAP HeadgearHG2062026-06-04
00848530109103CPAP HeadgearHG2072026-06-04
00848530108328Repair PartsRP0932026-06-03
00848530109097CPAP MaskCM060S2026-06-03
00848530109264CPAP MaskCM060M2026-06-03
00848530109271CPAP MaskCM060L2026-06-03
00848530109288CPAP MaskCM060XL2026-06-03
00848530108953Repair PartsRP1082026-06-02
00848530108960Repair PartsRP1092026-06-02
00848530108977Repair PartsRP1102026-06-02
00848530109011Repair PartsRP1112026-06-02
00848530109028Repair PartsRP1122026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904428744954OSSEOUS- Tube Cleaning Brush - 8mmEON MEDITECH PRIVATE LIMITEDEPE2026-03-13
08904428798483OSSEOUS- Tube Cleaning Brush - 8mmEON MEDITECH PRIVATE LIMITEDEPE2026-03-13
07331791011412Provox Swab SmallAtos Medical ABEPE2025-10-24
07331791011429Provox Swab MediumAtos Medical ABEPE2025-10-24
07331791011436Provox Swab LargeAtos Medical ABEPE2025-10-24
07331791012730Provox Swab XtraLargeAtos Medical ABEPE2025-10-24
00848530085414CPAP Cleaning KitSUNSET HEALTHCARE SOLUTIONS, INC.EPE2025-04-14
00848253004013Cleaning Brush, StandardFreudenberg Medical, LLCEPE2025-03-25
00848253004020Cleaning Brush, LongFreudenberg Medical, LLCEPE2025-03-25
00348783005110Premier Tracheal Tube BrushPREMIER DENTAL PRODUCTS COMPANYEPE2024-08-06
00348783005127Premier Tracheal Tube BrushPREMIER DENTAL PRODUCTS COMPANYEPE2024-08-06
00630094174044Bioseal Inc.BIOSEALEPE2023-09-18
00630094174099Bioseal Inc.BIOSEALEPE2023-09-18
10630094174041Bioseal Inc.BIOSEALEPE2023-09-18
10630094174096Bioseal Inc.BIOSEALEPE2023-09-18
07331791002656Provox TubeBrush 8 mmAtos Medical ABEPE2022-11-25
07331791002663Provox TubeBrush 12 mmAtos Medical ABEPE2022-11-25
07331791016493Provox TubeBrush 8 mmAtos Medical ABEPE2022-11-25
07331791016509Provox TubeBrush 12 mmAtos Medical ABEPE2022-11-25
14063107102674Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
14063107102681Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
14063107102698Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
14063107102704Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
34063107102678Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
34063107102685Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
34063107102692Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
34063107102708Trach Tube Cleaning BrushesBoston Medical Products, Inc.EPE2022-09-30
10080196466863ML-CANADAMEDLINE INDUSTRIES, INC.EPE2022-01-01
00653160004755CenturionCENTURION MEDICAL PRODUCTS CORPORATIONEPE2022-01-01
50653160004750CenturionCENTURION MEDICAL PRODUCTS CORPORATIONEPE2022-01-01