FDA.report

HYDROCLEANSE™

Primary DI
00643169864429
Company
MEDTRONIC XOMED, INC.
Model
1960100
Device description
DEVICE 1960100 SINUS WASH SYSTEM
Published
2018-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
835465063
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
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00643169864429PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00643169864429PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
KARIrrigator, Sinus1Ear, Nose, Throat874.4420NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Nasal irrigation set, clinicalA collection of sterile items intended to dispense a solution to penetrate, clear, and clean the nasal passages and sinus cavity for the relief of nasal and sinus symptoms (e.g., nasal congestion, sinus pressure, secretions, nasopharyngeal discharge, encrustations, nasal dryness) and/or before, during and/or after ENT surgery. It typically includes an irrigation bottle/canister/syringe which can include a pumping mechanism, actuator tips and adaptors for various solution-delivery applications and connector tubing. This device is intended to be used by a professional in a clinical setting. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

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