AccessGUDID - DEVICE: Environ-mate (B325DM600021)

GUDID

Device Identifier (DI) Information

Brand Name: Environ-mate
Version or Model: DM6000-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DM60002
Company Name: M D Technologies Inc.

Primary DI Number: B325DM600021
Issuing Agency: HIBCC
Commercial Distribution End Date: July 31, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 859679045 *Terms of Use

Device Description: Suction-Drain System to collect body fluids and dispose of them via sanitary sewer. One unit with two collectors.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
66200	Suction/irrigation system canister/bottle holder, reusable	A device intended to be used to hold a dedicated fluid or collection/specimen canister or bottle that is used within a suction and/or irrigation system. This device can be used to mount the canister/bottle(s) to the parent system when it is mobile (on wheels), or to mount the canister/bottle to a medical device service rail system or a wall rail (typically used on the ward). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDQ	Bottle, Collection, Vacuum

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: 74e82936-9bd8-41fa-ab3d-57ab2c09b116
Public Version Date: August 15, 2022
Public Version Number: 1
DI Record Publish Date: August 05, 2022