FDA.reportPublic FDA data

REBOA Catheter

Primary DI
10887714024990
Brand
REBOA Catheter
Company
NUMED, INC.
Model
362
Catalog number
RB202030
Device description
A coaxial catheter recommended for temporary occlusion of the aorta.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MJNCatheter, Intravascular Occluding, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160598000REBOA Balloon CatheterNuMED, Inc.2016-06-20MJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887714024990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088771402499010887714024990

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
114186877
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887714012140Tearduct Catheter352TD1002016-09-20
10887714024518SF-NIH317SF3602016-09-15
10887714024525SF-NIH317SF4602016-09-15
10887714024549REBOA Catheter362RB1530302016-09-16
10887714024556REBOA Catheter362RB1530502016-09-16
10887714024563REBOA Catheter362RB1530702016-09-16
10887714024570REBOA Catheter362RB1540302016-09-16
10887714024587REBOA Catheter362RB1540502016-09-16
10887714024594REBOA Catheter362RB1540702016-09-16
10887714024600REBOA Catheter362RB2030302016-09-19
10887714024617REBOA Catheter362RB2030502016-09-19
10887714024624REBOA Catheter362RB2030702016-09-19
10887714024631REBOA Catheter362RB2040302016-09-19
10887714024648REBOA Catheter362RB2040502016-09-19
10887714024655REBOA Catheter362RB2040702016-09-19
10887714024662REBOA Catheter362RB2530302016-09-19
10887714024679REBOA Catheter362RB2530502016-09-19
10887714024686REBOA Catheter362RB2530702016-09-19
10887714024693REBOA Catheter362RB2540302016-09-19
10887714024709REBOA Catheter362RB2540502016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810060550816Bridge Plus occlusion balloonPhilips Image Guided Therapy CorporationMJN2025-10-09
00850001105118Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.MJN2025-06-20
00842429117545SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117552SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117569SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117583SCEPTERMicrovention, Inc.MJN2025-04-30
00842429106884Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106891Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106907Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106945Balloon CatheterMicrovention, Inc.MJN2025-04-22
10628678061054COBRA-OS®Front Line Medical Technologies Inc.MJN2024-03-22
10628678061061Syringe, 10 mLFront Line Medical Technologies Inc.MJN2024-03-22
B090LRN0590LANDMARKZIEN MEDICAL TECHNOLOGIES, INC.MJN2024-01-23
B090LRN0591LANDMARKZIEN MEDICAL TECHNOLOGIES, INC.MJN2024-01-23
10628678061009COBRA-OS™Front Line Medical Technologies Inc.MJN2023-08-25
10628678061016COBRA-OS™Front Line Medical Technologies Inc.MJN2023-08-25
10628678061023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2023-08-25
20763000293424Cadence ™ Precision Injector Thread 1 mL SyringeMicro Therapeutics, Inc.MJN2022-12-23
00850001105057Prytime Medical Devices Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00850001105064Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00842429103388Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103395Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103401Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103418Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429106563Balloon CatheterMicrovention, Inc.MJN2022-06-14
00853359008414SniperEmbolx, Inc.MJN2022-05-18
16286780610016COBRA-OS™Front Line Medical Technologies Inc.MJN2022-02-09
16286780610023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2022-02-09
16286780610009COBRA-OS™Front Line Medical Technologies Inc.MJN2022-01-28
00853892004447Terumo Aortic BalloonQXMEDICALMJN2021-09-03