AccessGUDID - DEVICE: Ethox Medical (10889483150047)

GUDID

Device Identifier (DI) Information

Brand Name: Ethox Medical
Version or Model: 950095603
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ETHOX MEDICAL, LLC

Primary DI Number: 10889483150047
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079149179 *Terms of Use

Device Description: Gastric Lavage Kit with 32fr Tubes and (2) 25g Activated Charcoal with Aqua

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":	Yes
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
KDH	Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962850	000

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: General Warehouse. Do not get wet.

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 32 French

Device Record Status

Public Device Record Key: e7e9d73c-4ddf-4c15-bb48-e65ba2799fdc
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 29, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20889483150044	10	10889483150047		In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-433-2797
Email: info@sun-med.com

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