FDA.reportPublic FDA data

CPAP Accesory

Primary DI
00848530020019
Brand
CPAP Accesory
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
CAP003
Device description
CPAP Pressure Meter
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
BXYFlowmeter, Calibration, Gas

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXYFlowmeter, Calibration, GasAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530020019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530020019008485300200198485300200190848530020019

GMDN Terms#

Term, Definition table
TermDefinition
Medical gas flowmeter, Bourdon gaugeA device intended to measure and regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It is a fixed-orifice device with an adjustable valve that controls the gas flow rate, and includes a calibrated Bourdon tube pressure gauge intended to measure pressure and display it as flow rate. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical 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
Manufacturing date on label
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
00848530108656Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BXY2026-03-17
00850027043845Precision Medical Inc.Precision Medical, Inc.BXY2026-02-25
00848530105204REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.BXY2025-08-27
00848530105501REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.BXY2025-08-27
20848530105208REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.BXY2025-08-27
10848530105508REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.BXY2025-08-27
00026072022443EMAllied Medical, LLCBXY2024-09-16
00026072022450EMAllied Medical, LLCBXY2024-09-16
00026072022467EMAllied Medical, LLCBXY2024-09-16
00026072022474EMAllied Medical, LLCBXY2024-09-16
00026072022481EMAllied Medical, LLCBXY2024-09-16
B366U1RH1011R-FLOWMETEREclerisBXY2024-08-16
00817770025863ManifoldMAXTEC, LLCBXY2024-08-14
00817770025870ManifoldMAXTEC, LLCBXY2024-08-14
00817770025955ManifoldMAXTEC, LLCBXY2024-08-14
00026072022511EMAllied Medical, LLCBXY2024-05-28
07640214642837FlowMeter F1IMT Analytics AGBXY2023-09-18
07640214642844FlowMeter F2IMT Analytics AGBXY2023-09-18
07640214642851FlowMeter F1IMT Analytics AGBXY2023-09-18
07640214642868FlowMeter F2IMT Analytics AGBXY2023-09-18
00851440007599Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.BXY2023-06-12
00851440007605Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.BXY2023-06-12
00851440007612Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.BXY2023-06-12
00817770022442BlenderBuddyMAXTEC, LLCBXY2023-06-08
00817770025726FlowmeterMAXTEC, LLCBXY2023-06-08
00817770025733FlowmeterMAXTEC, LLCBXY2023-06-08
00817770025740FlowmeterMAXTEC, LLCBXY2023-06-08
07640214642400CITREX H4IMT Analytics AGBXY2022-11-17
07640214642417CITREX H5IMT Analytics AGBXY2022-11-17
07640214642448Flow Analyzer PF-300IMT Analytics AGBXY2022-11-17