FDA.reportPublic FDA data

Disposable Duralon Occlusion Balloon - 2 Lumen

Primary DI
00813353010165
Brand
Disposable Duralon Occlusion Balloon - 2 Lumen
Company
Telemed Systems
Model
1720
Device description
Duralon Occlusion BalloonFour Size Variable Balloon10.0mm, 13.0mm, 16.5mm, 20.0mm7fr to 5fr Shaft Size x 200cm Catheter LengthProximal Injection Port
Published
2023-07-19
Public version status
New
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
FGEStents, Drains And Dilators For The Biliary Ducts

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013737000MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOONTelemed Systems, Inc.2002-03-01FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813353010165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813353010165008133530101658133530101650813353010165

GMDN Terms#

Term, Definition table
TermDefinition
ERCP catheter, balloon, non-electrical, stone-retrievalA flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017939239
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813353010080Disposable Sure-Flex Biliary Balloon Dilatation Catheter13422023-07-12
00813353010097Disposable Sure-Flex Biliary Balloon Dilatation Catheter13442023-07-12
00813353010103Disposable Sure-Flex Biliary Balloon Dilatation Catheter13462023-07-12
00813353010110Disposable Progressive Pressure Dilators14152023-07-12
00813353010127Disposable Progressive Pressure Dilators14182023-07-12
00813353010196Disposable Sclerotherapy Needle20022023-08-24
00813353010202Disposable Sclerotherapy Needle20042023-08-24
00813353010219Disposable Sclerotherapy Needle20062023-08-24
00813353010226Disposable Sclerotherapy Needle20082023-08-24
00813353010233Disposable Sclerotherapy Needle20102023-08-24
00813353010240Disposable Sclerotherapy Needle20142023-08-24
00813353010257Disposable Sclerotherapy Needle20152023-08-24
00813353010264Disposable Sclerotherapy Needle20162023-08-24
00813353010271Disposable Sclerotherapy Needle20182023-08-24
00813353010288Disposable Transbronchial Needle21022023-08-24
00813353010295Disposable Gastrointestinal Cytology Brush30022023-08-24
00813353010301Disposable Gastrointestinal Cytology Brush30042023-08-24
00813353010318Disposable Gastrointestinal Cytology Brush30062023-08-24
00813353010325Disposable Gastrointestinal Cytology Brush30082023-08-24
00813353010332Disposable Gastrointestinal Cytology Brush30102023-08-24

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Primary DI, Brand, Company table
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15711055120040M-DrainMermaid Medical A/SFGE2024-01-31
15711055120453M-DrainMermaid Medical A/SFGE2024-01-31
15711055000311M-DrainMermaid Medical A/SFGE2016-09-24
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15711055000410M-DrainMermaid Medical A/SFGE2016-09-24
15711055000434M-DrainMermaid Medical A/SFGE2016-09-24
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15711055000595M-DrainMermaid Medical A/SFGE2016-09-24
15711055000625M-DrainMermaid Medical A/SFGE2016-09-24
15711055000632M-DrainMermaid Medical A/SFGE2016-09-24
15711055000663M-DrainMermaid Medical A/SFGE2016-09-24
15711055000670M-DrainMermaid Medical A/SFGE2016-09-24
15711055000700M-DrainMermaid Medical A/SFGE2016-09-24
15711055000724M-DrainMermaid Medical A/SFGE2016-09-24
15711055000748M-DrainMermaid Medical A/SFGE2016-09-24
15711055000762M-DrainMermaid Medical A/SFGE2016-09-24
15711055000779M-DrainMermaid Medical A/SFGE2016-09-24
15711055000809M-DrainMermaid Medical A/SFGE2016-09-24
15711055000816M-DrainMermaid Medical A/SFGE2016-09-24