FDA.report

CLEARinse

Primary DI
B423CRPRO1
Brand
CLEARinse
Company
PENO LLC
Model
Pro
Device description
The CLEARinse Pro is designed to make nasal and sinus lavage easy and convenient. The device facilitates instillation of saline into the nasal passag
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JCXApparatus, Suction, Ward Use, Portable, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
JCXApparatus, Suction, Ward Use, Portable, Ac-PoweredGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B423CRPRO1PrimaryHIBCC0

GMDN Terms

TermDefinition
Nasal aspirator, electricA portable, hand-held, battery-powered suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It consists of a handgrip that contains the batteries, a small electric pump that creates the suction, and typically has a silicone nozzle attached to a detachable, washable, collection cup at the distal end. It is designed for domestic use and is typically applied superficially the nasal opening (i.e., not inserted into the nasal cavity). This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
877-737-9177info@pneo.org

Regulatory Flags

DUNS number
828917653
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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 Sharing Product Codes

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10612479280554McKessonMCKESSON MEDICAL-SURGICAL INC.JCX2025-12-03
00763000915681Riptide™ Aspiration PumpMicro Therapeutics, Inc.JCX2025-08-18
04719876940186ZOOM™ Duoport CanisterTaiwan Biomaterial Company LimitedJCX2025-02-24
07613327644067NeptuneSTRYKER CORPORATIONJCX2024-12-06
00092237626689Roscoe MedicalCOMPASS HEALTH BRANDS CORP.JCX2024-11-19
00885304032557DeVilbissDEVILBISS HEALTHCARE LLCJCX2024-11-08
00885304032571DeVilbissDEVILBISS HEALTHCARE LLCJCX2024-11-08
37613327566162NeptuneSTRYKER CORPORATIONJCX2024-10-15
10848530091290Power and AccessoriesSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
00848530091378Portable SuctionSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
10848530091870Power and AccessoriesSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
00848530096199Portable SuctionSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
00848530096205Closed SuctionSUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-08-08
07613327634914NeptuneSTRYKER CORPORATIONJCX2024-04-16
10848530102576Sunset Portable Suction Machine with AC/DC Power SUNSET HEALTHCARE SOLUTIONS, INC.JCX2024-03-05
04719876940124TRUVIC GeneratorTaiwan Biomaterial Company LimitedJCX2024-02-19
00840117326576Respo-O2 Homecare Suction Unit, Portable, Batter Operated DYNAREX CORPORATIONJCX2023-12-29
40050428550012CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDJCX2023-03-09
00840329811488N/ABLACK & BLACK SURGICAL, INC.JCX2022-09-21
B089B786100N/ABLACK & BLACK SURGICAL, INC.JCX2022-09-12
00840117309609Resp-O2 Suction Unit DYNAREX CORPORATIONJCX2022-05-09
00840117309623Resp-O2 Suction Unit With BaseDYNAREX CORPORATIONJCX2022-05-09
04719876940094TRUVIC GeneratorTAIWAN BIOMATERIAL COMPANY LIMITEDJCX2022-02-21
04719876940100TRUVIC GeneratorTAIWAN BIOMATERIAL COMPANY LIMITEDJCX2022-02-21
04719876940117TRUVIC GeneratorTAIWAN BIOMATERIAL COMPANY LIMITEDJCX2022-02-21
70889024471169IntelliCart™ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JCX2022-02-07
00889024501621IntelliCart™ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JCX2022-02-03
00889024501638IntelliCart™ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JCX2022-02-03
00889024501645IntelliCart™ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JCX2022-02-03