FDA.reportPublic FDA data

ReddyPort

Primary DI
00850001175005
Brand
ReddyPort
Company
SMD Manufacturing LLC
Model
RP-531-L1
Device description
Multi-functional NIV elbow for Philips Respironics 531 and Performax Masks, Leak 1
Published
2020-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNSVentilator, Continuous, Non-Life-Supporting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNSVentilator, Continuous, Non-Life-SupportingAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171827000ReddyPort NIV Access ElbowSmd Manufacturing, LLC2018-01-19MNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850001175002PackageGS110In Commercial Distribution
20850001175009PackageGS150In Commercial Distribution
30850001175006PackageGS1200In Commercial Distribution
00850001175005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000117500210850001175002
2085000117500920850001175009
3085000117500630850001175006
00850001175005008500011750058500011750050850001175005

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
+1 (801) 899-3036info@reddyport.com

Regulatory Flags#

DUNS number
070849038
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851780008003LineLogic™LL-M-62022-08-01
00851780008102LineLogic™LL-M-72022-08-01
00851780008201LineLogic™LL-M-82022-08-01
00850001175029ReddyPortRP-541-L12024-01-16
00850001175067ReddyPortRP-541-L22024-01-16
00850001175074ReddyPortRP-541-SE2024-01-16
10850001175026ReddyPortRP-541-L12024-01-16
10850001175064ReddyPortRP-541-L22024-01-16
10850001175071ReddyPortRP-541-SE2024-01-16
00850001175227ReddyPortRP-MKITQ4-22023-07-12
10850001175224ReddyPortRP-MKITQ4-22023-07-12
10851780008000LineLogic™LL-M-62022-08-01
10851780008109LineLogic™LL-M-72022-08-01
10851780008208LineLogic™LL-M-82022-08-01
00850001175210ReddyPortRP-MKITQ4-12020-11-18
10850001175217ReddyPortRP-MKITQ4-12020-11-18
00850001175203Moisturizer RP-MPK-12020-11-18
10850001175002ReddyPortRP-531-L12020-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08401934313389ResScanRESMED CORP.MNS2023-02-24
08401934313396ResScanRESMED CORP.MNS2023-02-24
00606959049024DreamMapper Web (DM)Respironics, Inc.MNS2020-10-16
00606959049031DreamMapper Web (EMEA)Respironics, Inc.MNS2020-10-16
00606959049048DreamMapper Web (APAC)Respironics, Inc.MNS2020-10-16
00606959049055DreamMapper Mobile App Android (DMM)Respironics, Inc.MNS2020-10-16
00606959049086DreamMapper App iOSRespironics, Inc.MNS2020-10-16
00606959049093DreamMapper App iOS (EMEA)Respironics, Inc.MNS2020-10-16
00606959049840Care OrchestratorRespironics, Inc.MNS2020-10-16
00606959049109DreamMapper App iOS (APAC)Respironics, Inc.MNS2020-10-07
00606959044203Care OrchestratorRespironics, Inc.MNS2020-09-23
00606959052093DreamMapper Web (DM)Respironics, Inc.MNS2020-05-20
00606959053519DreamMapper Web (EMEA)Respironics, Inc.MNS2020-05-20
00606959033344Li Ion Battery, Ventilation, JapanRespironics, Inc.MNS2019-06-05
00606959049871DreamMapper Web (APAC)Respironics, Inc.MNS2019-04-19
00606959049925DreamMapper Android China Instance v 2.11Respironics, Inc.MNS2019-04-19
00606959049888DreamMapper Web China Instance v 2.11Respironics, Inc.MNS2019-04-18
00606959049895DreamMapper Mobile App Android (DMM)Respironics, Inc.MNS2019-04-18
00606959049901DreamMapper Mobile App Android (EMEA)Respironics, Inc.MNS2019-04-18
00606959049918DreamMapper Mobile App Android (APAC)Respironics, Inc.MNS2019-04-18
00606959033306BatteryRespironics, Inc.MNS2019-03-04
00606959054820EncoreAnywhereRespironics, Inc.MNS2019-01-14
00606959054837EncoreAnywhereRespironics, Inc.MNS2019-01-14
00606959053984Care Orchestrator EssenceRespironics, Inc.MNS2018-12-20
00606959054790Care OrchestratorRespironics, Inc.MNS2018-12-10
00606959054189DreamMapperRespironics, Inc.MNS2018-10-30
00606959054196DreamMapperRespironics, Inc.MNS2018-10-30
00606959054202DreamMapperRespironics, Inc.MNS2018-10-30
00606959054219DreamMapperRespironics, Inc.MNS2018-10-30
00606959054226DreamMapperRespironics, Inc.MNS2018-10-30