AccessGUDID - DEVICE: Geri Embryo Incubator (09348265003000)

GUDID

Device Identifier (DI) Information

Brand Name: Geri Embryo Incubator
Version or Model: GERI-INS-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENEA BIOMEDX PTY LTD

Primary DI Number: 09348265003000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 752103403 *Terms of Use

Device Description: The Geri Embryo Incubator is a benchtop incubator with six modular incubation chambers each with its own temperature control capability and separate gas inlet feed. Each chamber contains heating elements in its lid and base, together with an orange light source (591 nm) and camera with integrated optics that take time-lapse images of embryos and allows operators to view embryos without removing them from the incubation chamber. Inside each chamber is a filter used to filter the gas mixture entering the incubation chamber from the gas supply. The gas is supplied from standard premixed medical gas cylinders. The Geri Embryo Incubator includes firmware to control the incubator settings, and software to control patient information and settings.

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):	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?
44290	Assisted reproduction heater/incubator	An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQK	Labware, Assisted Reproduction
MQG	Accessory, Assisted Reproduction
MTX	Microscope And Microscope Accessories,Reproduction,Assisted

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171736	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 055c2f58-079e-42f5-9788-255ede47f67b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 08, 2017