AccessGUDID - DEVICE: Gastric Lavage Kit with 32 Fr. Lavage Tube (00860474000315)

GUDID

Device Identifier (DI) Information

Brand Name: Gastric Lavage Kit with 32 Fr. Lavage Tube
Version or Model: MTM5132
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MTM5132
Company Name: MASON TAYLER MEDICAL

Primary DI Number: 00860474000315
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176382489 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58985	Gastric lavage kit	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQT	Evacuator, Gastro-Urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c4738f24-4afd-4c20-a41d-7273b8c5ebff
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 25, 2016