FDA.reportPublic FDA data

Ethox Medical

Primary DI
20889483131135
Brand
Ethox Medical
Company
ETHOX MEDICAL, LLC
Model
450087400
Device description
24fr Lavage Tubes
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDHCatheter (Gastric, Colonic, Etc.), Irrigation And AspirationGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K860599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K860599000ETHOX LAVAGE TUBEEthox Corp.1986-03-11KDH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483131135PackageGS110In Commercial Distribution
10889483131138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948313113520889483131135
1088948313113810889483131138

GMDN Terms#

Term, Definition table
TermDefinition
Gastric lavage kitA collection of non-sterile devices intended to be used for the manual irrigation, washing, and evacuation of debris (toxic substances) from the stomach. It typically consists of supply/drain bags with lavage and ancillary tubing; activated charcoal may be included. The tubing is intended to be inserted into the nose or mouth of the patient to contact the gastric mucosa where fluids are introduced and removed using gravity. The device is typically used by healthcare providers in clinics and emergency/trauma departments. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge24French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00General Warehouse. Do not get wet.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
079149179
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20889483160081EthoxVC505VC5052023-03-21
20889483160098EthoxVC510VC5102023-03-21
20889483160104EthoxVC530VC5302023-03-21
20889483149703Ethox9500890009500890002023-03-21
20889483149741Ethox9500893009500893002023-03-21
20889483149758Ethox9500894009500894002023-03-21
20889483149765Ethox9500895009500895002023-03-21
20889483149772Ethox9500896009500896002023-03-21
20889483149970Ethox9500931009500931002023-03-21
20889483149994Ethox9500935009500935002023-03-21
10889483130964Ethox Medical4500814002016-09-28
10889483131138Ethox Medical4500874002016-09-29
10889483131145Ethox Medical4500875002016-09-29
10889483150030Ethox Medical9500942012016-09-27
10889483149782Ethox Medical9500897002016-09-29
10889483084311EthoxVC405VC4052023-03-21
10889483110072EthoxVC410VC4102023-03-21
10889483110782EthoxVC430VC4302023-03-21
20889483149710Ethox9500891009500891002023-03-21
20889483149727Ethox9500892009500892002023-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850082007100Aspiration TubingARMM INC.KDH2023-06-08
10850082007117Aspiration TubingARMM INC.KDH2023-06-08
10850082007124Aspiration TubingARMM INC.KDH2023-06-08
00850082007103Aspiration TubingARMM INC.KDH2023-06-08
00850082007110Aspiration TubingARMM INC.KDH2023-06-08
00850082007127Aspiration TubingARMM INC.KDH2023-06-08
10192253013016ArgyleCardinal Health 200, LLCKDH2022-10-26
10192253013023ArgyleCardinal Health 200, LLCKDH2022-10-26
50192253013014ArgyleCardinal Health 200, LLCKDH2022-10-26
50192253013021ArgyleCardinal Health 200, LLCKDH2022-10-26
00350770927961Aspiration CatheterAvanos Medical, Inc.KDH2019-09-10
10350770927968AVANOSAvanos Medical, Inc.KDH2019-09-10
00350770927749Injection Needle CatheterAvanos Medical, Inc.KDH2019-07-27
00350770927756Injection Needle CatheterAvanos Medical, Inc.KDH2019-07-27
00350770927800Injection Needle CatheterAvanos Medical, Inc.KDH2019-07-27
10350770927746AVANOSAvanos Medical, Inc.KDH2019-07-27
10350770927753AVANOSAvanos Medical, Inc.KDH2019-07-27
10350770927807AVANOSAvanos Medical, Inc.KDH2019-07-27
00815277020084CuraplexBOUND TREE MEDICAL, LLCKDH2016-12-16
00827002165717SilberCOOK INCORPORATEDKDH2016-11-04
30884527000108ArgyleCardinal Health, Inc.KDH2016-10-14
10884527000104ArgyleCardinal Health, Inc.KDH2016-10-14
30884527000092ArgyleCardinal Health, Inc.KDH2016-10-13
20884527000095ArgyleCardinal Health, Inc.KDH2016-10-13
10889483131138Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
10889483131145Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
10889483150047Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
10889483150054Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
10889483150061Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
20889483131142Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29