FDA.reportPublic FDA data

EcoGel 200

Primary DI
00628055650676
Brand
EcoGel 200
Company
Eco-Med Pharmaceutical Inc
Model
40JSPC
Device description
Clear 20g Packet
Published
2020-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955246000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955246000ECOGEL 200 ULTRASOUND GELEco-Med Pharmaceuticals, Inc.1996-02-21ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628055650683PackageGS1400In Commercial Distribution
00628055650676PrimaryGS10
00628055650669Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055650683006280556506836280556506830628055650683
00628055650676006280556506766280556506760628055650676
00628055650669006280556506696280556506690628055650669

GMDN Terms#

Term, Definition table
TermDefinition
Skin topical coupling gelA medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system,) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light, blood gas) that pass through the skin during an examination or treatment. Also known as contact gel, it is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
249183435
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055650485EcoGel 200 40JSP2020-01-15
00628055650508EcoGel 200 40JSPC-HV2020-01-15
00628055650577EcoGel 200 40JSP-HV2020-01-15
00628055650737EcoGel 200 Clear40JBC-HV-242020-12-18
00628055650942EcoGel 200 40JB-HV2020-01-15
00628055650966EcoGel 20040JSC-HV2020-01-15
00628055650997EcoGel 200 40JS-HV2020-01-15
00628055650317Ecogel 10030GB2016-08-23
00628055650324Ecogel 10030GB2016-08-23
00628055650331Ecogel 10030GS2016-08-23
00628055650348Ecogel 10030GS2016-08-23
00628055650355Ecogel 10030GM2016-08-23
00628055650362Ecogel 10030JM2016-08-23
00628055650379Ecogel 10030JM2016-08-23
00628055650386Ecogel 10030GBB2016-08-23
00628055650416Ecogel 20040JB2016-08-23
00628055650423Ecogel 20040JB2016-08-23
00628055650430Ecogel 20040JBB2016-08-23
00628055650447Ecogel 20040JS2016-08-23
00628055650454Ecogel 20040JS2016-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27