AccessGUDID - DEVICE: Environ-mate (B325PT20101)

GUDID

Device Identifier (DI) Information

Brand Name: Environ-mate
Version or Model: PT20-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PT2010
Company Name: M D Technologies Inc.

Primary DI Number: B325PT20101
Issuing Agency: HIBCC
Commercial Distribution End Date: July 31, 2025
Device Count: 10
Labeler D-U-N-S® Number*: 859679045 *Terms of Use

Device Description: Polyp Trap with screw top, fine-mesh screen and plain tube. Package of 10.

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):	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?
34858	Surgical suction system collection container, single-use	A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYZ	Trap, Sterile Specimen

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
Storage Environment Temperature: between 35 and 120 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: effc506f-b15a-4577-9da4-01fc364f0a66
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: August 05, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B325PT20252	25	B325PT20100	2025-07-31	In Commercial Distribution	Box
B325PT20503	50	B325PT20100	2025-07-31	In Commercial Distribution	Box
B325PT201004	100	B325PT20100	2025-07-31	In Commercial Distribution	Box