FDA.reportPublic FDA data

Elation™

Primary DI
00884450398999
Brand
Elation™
Company
Merit Medical Systems, Inc.
Model
00884450398999
Catalog number
P6L30/A
Published
2018-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KTIBronchoscope accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTIBronchoscope AccessoryEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161392000Elation Pulmonary Balloon DilationMerit Medical Systems, Inc.2016-09-01KTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884450398999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450398999008844503989998844503989990884450398999

GMDN Terms#

Term, Definition table
TermDefinition
Bronchial balloon catheterA sterile flexible tube designed with a balloon at or near the distal tip that may be introduced directly (usually under fluoroscopic guidance) or through a bronchoscope so that its distal tip reaches the bronchi, permitting the inflation of the balloon after introduction. The device is typically used to treat benign stenosis and strictures of the airway and/or to control pulmonary bleeding (i.e., hemoptysis). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450014523ReSolve®, StayFIX®,ARLCMB-NV-10-SFX2026-07-16
00884450161777Merit Medical®Initial ReleaseK09-10897B2026-07-16
00884450432075Merit Medical®Initial ReleaseK11-01125B2026-07-16
00884450434482Merit Medical®Initial ReleaseK10-05031A2026-07-14
00884450493182Merit Medical®Initial ReleaseK09-09809C2026-07-14
00884450493199Merit Medical®Initial ReleaseK11-014882026-07-14
00884450108765Merit Medical®Initial ReleaseK09-10721A2026-07-10
00884450450949Merit Medical®Initial ReleaseK09-143532026-07-11
00884450487334Merit Medical®Initial ReleaseK11-014852026-07-10
00884450487341Merit Medical®Initial ReleaseK12-127232026-07-10
00884450492956Merit Medical®Initial ReleaseK10T-061782026-07-11
00884450486436Merit Medical®Initial ReleaseK09-144172026-07-09
00884450488812Merit Medical®Initial ReleaseK17-00021A2026-07-09
00884450437698Merit Medical®Initial ReleaseK09-09854C2026-07-08
00884450468913DuraMax®CH7871030280252026-07-08
00884450487273Merit Medical®Initial ReleaseK12T-02285H2026-07-08
00884450846254Flex-Neck®CCF-52602026-07-08
10884450415631Prelude®JPSI-6F-11-0252026-07-08
10884450415655Prelude®JPSI-6F-11-035-18G2026-07-08
10884450707781Prelude®FPSI-6F-11-0252026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06009698453161Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453178Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453185Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453208Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453215Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453222Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453239Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453246Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-20
06009698453192Trachealator Non-occlusive Airway Dilation BalloonDISA MEDINOTEC (PTY) LTDKTI2026-05-19
00860009430242Adapter SRA-2-01 SERPEX MEDICAL INC.KTI2025-12-08
00860009430211Compass Steerable NeedleSERPEX MEDICAL INC.KTI2025-12-08
00860009430235Adapter SRA-1-01 SERPEX MEDICAL INC.KTI2025-12-08
10860009430249Adapter SRA-2-01 SERPEX MEDICAL INC.KTI2025-12-08
00816734023518BullDog®DIVERSATEK HEALTHCARE, INC.KTI2025-12-05
10816734023515BullDog®DIVERSATEK HEALTHCARE, INC.KTI2025-12-05
00850081350002Ion Pouch FRPRAXIS MEDICAL LLCKTI2025-11-06
00850081350019Monarch Pouch BVPRAXIS MEDICAL LLCKTI2025-11-06
00850081350026Monarch Pouch FRPRAXIS MEDICAL LLCKTI2025-11-06
00850081350033Olympus Pouch BVPRAXIS MEDICAL LLCKTI2025-11-06
00850081350040Olympus Pouch FRPRAXIS MEDICAL LLCKTI2025-11-06
00860003935842EndoCorePRAXIS MEDICAL LLCKTI2025-11-06
00860003935859Ion Pouch BVPRAXIS MEDICAL LLCKTI2025-11-06
04953170458378Single Use Aspiration Needle NA-201SX-4021OLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
04953170458385Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
04953170458392Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
04953170458408Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458375Single Use Aspiration Needle NA-201SX-4021OLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458382Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458399Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14
14953170458405Single Use Aspiration NeedleOLYMPUS MEDICAL SYSTEMS CORP.KTI2025-08-14