Ethox Medical

Primary DI
10889483150078
Brand
Ethox Medical
Company
ETHOX MEDICAL, LLC
Model
950095903
Device description
Gastric Lavage Kit with 32fr Lavage Tubes & 3L Bag
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K962850000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962850000TUM-E-VACEthox Corp.1997-02-21KDH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483150075PackageGS110In Commercial Distribution
10889483150078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948315007520889483150075
1088948315007810889483150078

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.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
079149179
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
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
20889483131135Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29