FDA.reportPublic FDA data

RELIEVA TRACT

Primary DI
20705031462608
Brand
RELIEVA TRACT
Company
ACCLARENT, INC.
Model
RT1240A
Catalog number
RT1240A
Device description
RELIEVA TRACT BALLOON DILATION SYSTEM, 12X40MM
Published
2019-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QGKBalloon, nasal airway

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGKBalloon, Nasal AirwayEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183090000Relieva Tract Balloon Dilation SystemAcclarent, Inc.2019-04-19QGK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031462608PackageGS15In Commercial Distribution
10705031462601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503146260820705031462608
1070503146260110705031462601

GMDN Terms#

Term, Definition table
TermDefinition
Nasal/paranasal balloon catheterA sterile flexible tube with an inflatable balloon at its distal tip designed to gently restructure nasal passages and dilate obstructed sinus ostia during a surgical procedure (sinuplasty), typically to treat sinusitis, and/or to gently restructure nasal passages to temporarily relieve nasal obstruction/congestion. The device typically consists of a single-lumen tube with a connector at the proximal end for attachment to an inflation device. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)775-2789xxx@xxx.xxx
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
361092450
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
10705031063297INSPIRA AIRBC1040ABC1040A2016-09-01
10705031063310INSPIRA AIRBC1440ABC1440A2016-09-01
10705031131996INSPIRA AIRBC0524ABC0524A2016-09-01
10705031132061INSPIRA AIRBC0724ABC0724A2016-09-01
10705031147737INSPIRA AIRBC1240ABC1240A2016-09-01
10705031147744INSPIRA AIRBC1640ABC1640A2016-09-01
10705031206052INSPIRA AIRBC8524ABC8524A2016-09-01
20705031063089INSPIRA AIRBC0524AZBC0524AZ2016-09-01
20705031063126INSPIRA AIRBC0724AZBC0724AZ2016-09-01
20705031063157INSPIRA AIRBC1040AZBC1040AZ2016-09-01
20705031063171INSPIRA AIRBC1440AZBC1440AZ2016-09-01
20705031147703INSPIRA AIRBC1240AZBC1240AZ2018-03-31
20705031242682INSPIRA AIRBC8524AZBC8524AZ2018-03-31
10705031245853TruDi NAV CableTDNC001TDNC0012018-10-31
10705031245877TruDi NAV SuctionTDNS000ZTDNS000Z2019-01-20
10705031245884TruDi NAV SuctionTDNS070ZTDNS070Z2019-01-20
10705031245891TruDi NAV SuctionTDNS090ZTDNS090Z2019-01-20
20705031245867TruDi NAV CableTDNC001ZTDNC001Z2018-10-31
10705031200258RELIEVA ULTIRRABC0516RUBC0516RU2016-10-01
10705031200272RELIEVA ULTIRRABC0616RUBC0616RU2016-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031462588RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
10705031462601RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
10705031462625RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
10705031462649RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462585RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462622RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462646RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462592RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462615RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462639RELIEVA TRACTACCLARENT, INC.QGK2019-05-31
20705031462653RELIEVA TRACTACCLARENT, INC.QGK2019-05-31