AccessGUDID - DEVICE: MARS (00888937024708)

GUDID

Device Identifier (DI) Information

Brand Name: MARS
Version or Model: MARS 1500 LAF 5FT MARS WORKSTATION
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WM1500
Company Name: RESEARCH INSTRUMENTS LIMITED

Primary DI Number: 00888937024708
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 536139413 *Terms of Use

Device Description: In Vitro Fertilization IVF Workstation

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):	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?
20652	Class-I biological safety cabinet	A furniture-like device designed as a partial or total enclosure to provide a class I biosafety level (BSL) to the operator and the environment during the manipulation of microorganisms and other biological hazardous materials (usually up to category 3 pathogens). It typically utilizes laminar airflow (LAF), a high-efficiency particulate air (HEPA) filter and/or carbon filter, and may have a hydrogen peroxide (H2O2) connection as some of the protective mechanisms. It is used for handling cell cultures and human pathogens (e.g., bacteria, viruses, parasites) and other biohazardous materials, extremely toxic agents (e.g., chemotherapy drugs), and also for tissue culture and tumour virus work.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUB	Accessory, Assisted Reproduction, Exempt

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: f4487cd0-0251-4fb0-ad2e-b38579b24be6
Public Version Date: September 27, 2024
Public Version Number: 1
DI Record Publish Date: September 19, 2024