FDA.reportPublic FDA data

Naväge

Primary DI
00858492004545
Brand
Naväge
Company
Rhinosystems, Inc.
Model
OSS-1
Published
2018-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDQBottle, Collection, Vacuum
KMAIrrigator, Powered Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2
KMAIrrigator, Powered NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858492004545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858492004545008584920045458584920045450858492004545

GMDN Terms#

Term, Definition table
TermDefinition
Nasal lavage systemA device assembly designed for automated or semi-automated irrigation and washing of tissue and/or debris from the nose and/or the nasal sinuses. It typically consists of a main electromechanical unit that includes a pump for irrigation/infusion of a jet of non-medicated liquid (e.g., saline); controls for the rate and pressure of irrigation; a reservoir for the solution; and a handpiece that may include a set of detachable tips intended for introduction into the nostrils. The system is used mainly for allergy treatment, nasal congestion, and before and after surgery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-203-6400support@navage.com

Regulatory Flags#

DUNS number
008016231
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850079671010NavägeNEB-12026-03-02
00850027492995NavägeEAR-12026-02-23
00850079671003Naväge PNC-12026-02-23
00850027492889Naväge BabyBMM-12025-10-29
00850027492957NavägeLAV-12025-07-08
00858492004958NavägeALK-12024-06-20
00850027492698NavägeSNM-12024-11-15
00850027492728Naväge BabyASP-12024-11-15
00850027492735Naväge BabyBMM-12024-11-15
00858492004224NavägeSDG-2 OSS-12020-02-28
00858492004644NavägeEUC-12020-02-28
00858492004002Naväge SGD22016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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14026704911780PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-09-04
14026704911902PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-07-02
14026704911872PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911889PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911896PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911919PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911926PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911933PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
14026704911940PLEUR-EVACTELEFLEX INCORPORATEDKDQ2025-03-12
10192253002652Thora-SealCardinal Health 200, LLCKDQ2025-02-19
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10192253002676ArgyleCardinal Health 200, LLCKDQ2025-02-18
10073088165296BemisBEMIS MANUFACTURING COMPANYKDQ2025-02-07