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
Rx
false
OTC
false
Sterile
false
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
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
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
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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
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
07640214642394CITREX H3IMT Analytics AGBXY2022-11-17
07640214641946CITREX H4IMT Analytics AGBXY2022-11-17
07640214642165CITREX H5IMT Analytics AGBXY2022-11-17
07640214641243Flow Analyzer PF-300IMT Analytics AGBXY2022-11-17
07640214641250Flow Analyzer PF-301IMT Analytics AGBXY2022-11-17
07640214641267Flow Analyzer PF-302IMT Analytics AGBXY2022-11-17
07640214642714Flow Analyzer PF-300 PROIMT Analytics AGBXY2022-11-17