FDA.reportPublic FDA data

BALLOON

Primary DI
04953170463938
Brand
BALLOON
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-1351
Catalog number
N5369631
Published
2025-02-25
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)
FDSGastroscope And Accessories, Flexible/Rigid
ITXTransducer, Ultrasonic, Diagnostic
ODGEndoscopic Ultrasound System, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
ITXTransducer, Ultrasonic, DiagnosticRadiology2
ODGEndoscopic Ultrasound System, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170463938PrimaryGS10
84953170463934Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170463938049531704639384953170463938
8495317046393484953170463934

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound endoscope balloon, Hevea-latexA sterile balloon-like cap made of Hevea natural rubber latex (NRL) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
20
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170459207Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8019N62211302025-12-02
04953170459252Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8022N62213302025-12-02
04953170459313Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8025N62215302025-12-02
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21

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Primary DI, Brand, Company table
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00841517112462iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00841517139018iLOOKFUJIFILM SONOSITE, INC.ITX2026-07-16
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCITX2026-07-10
00191506062620RIVOS™BOSTON SCIENTIFIC CORPORATIONODG2026-06-25
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
06959664925645NAHangzhou AGS MedTech Co., Ltd.FDS2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FDS2026-06-18
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
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00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.EOQ2026-06-02
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.ODG2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.ODG2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.ODG2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28