FDA.reportPublic FDA data

Gastric Lavage Kit with 36 Fr. Lavage Tube

Primary DI
00860474000339
Brand
Gastric Lavage Kit with 36 Fr. Lavage Tube
Company
MASON TAYLER MEDICAL
Model
MTM5136
Catalog number
MTM5136
Published
2016-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQTEvacuator, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQTEvacuator, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860474000346PackageGS110In Commercial Distribution
00860474000339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860474000346008604740003468604740003460860474000346
00860474000339008604740003398604740003390860474000339

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-270-8097info@masontayler.com

Regulatory Flags#

DUNS number
176382489
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860474000308Gastric Lavage KitMTM5200MTM52002016-08-25
00860474000353Gastric Lavage KitMTM5200MTM52002016-08-25
00860474000315Gastric Lavage Kit with 32 Fr. Lavage TubeMTM5132MTM51322016-08-25

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