FDA.reportPublic FDA data

Disposable Progressive Pressure Dilators

Primary DI
00813353010110
Brand
Disposable Progressive Pressure Dilators
Company
Telemed Systems
Model
1415
Device description
PPD Gastrointestinal Dilator15-17mm Diameter x 8cm Length Balloon Dimension200cm Total Catheter Length
Published
2023-07-12
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
FGEStents, Drains And Dilators For The Biliary Ducts
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020379000PPD BALLOON DILATATION CATHETERTelemed Systems, Inc.2002-05-06KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813353010110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813353010110008133530101108133530101100813353010110

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/biliary dilation balloon catheterA long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. 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

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
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
00813353010349Disposable Gastrointestinal Cytology Brush30122023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01
00816340021649EL-SPIKE-FNEODEVICES INCKNT2026-06-01
00816340021656EL-S55-HFNEODEVICES INCKNT2026-06-01
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
15711055100400M-DrainMermaid Medical A/SFGE2024-10-01
15711055110041M-DrainMermaid Medical A/SFGE2024-07-20
15711055110409M-DrainMermaid Medical A/SFGE2024-07-20
08015262022259VYGONVygon CorporationKNT2024-05-08
08015262022242VYGONVygon CorporationKNT2024-03-14
15711055120040M-DrainMermaid Medical A/SFGE2024-01-31
15711055120453M-DrainMermaid Medical A/SFGE2024-01-31
08599110040065BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.KNT2016-10-26
08599110040072BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.KNT2016-10-26
08599110040089BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.KNT2016-10-26
08599110040096BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.KNT2016-10-26
08599110040102BIONIX DEVELOPMENT CORPORATIONM&H Medical Holdings, Inc.KNT2016-10-26
08714729142201EndoVive Low Profile Replacement ButtonBOSTON SCIENTIFIC CORPORATIONKNT2016-09-24
08714729142218EndoVive Low Profile Replacement ButtonBOSTON SCIENTIFIC CORPORATIONKNT2016-09-24
08714729284017EndoVive Low Profile Replacement ButtonBOSTON SCIENTIFIC CORPORATIONKNT2016-09-24
08714729284024EndoVive Low Profile Replacement ButtonBOSTON SCIENTIFIC CORPORATIONKNT2016-09-24
08714729284031EndoVive Low Profile Replacement ButtonBOSTON SCIENTIFIC CORPORATIONKNT2016-09-24
08714729284048EndoVive Low Profile Replacement ButtonBOSTON SCIENTIFIC CORPORATIONKNT2016-09-24
08714729284062EndoVive Low Profile Replacement ButtonBOSTON SCIENTIFIC CORPORATIONKNT2016-09-24
08714729284079EndoVive Low Profile Replacement ButtonBOSTON SCIENTIFIC CORPORATIONKNT2016-09-24
08714729284086EndoVive Low Profile Replacement ButtonBOSTON SCIENTIFIC CORPORATIONKNT2016-09-24
15711055000311M-DrainMermaid Medical A/SFGE2016-09-24
15711055000328M-DrainMermaid Medical A/SFGE2016-09-24
15711055000359M-DrainMermaid Medical A/SFGE2016-09-24
15711055000373M-DrainMermaid Medical A/SFGE2016-09-24
15711055000410M-DrainMermaid Medical A/SFGE2016-09-24