AccessGUDID - DEVICE: MIRI (04779041940106)

GUDID

Device Identifier (DI) Information

Brand Name: MIRI
Version or Model: MIRI
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ESCO MEDICAL TECHNOLOGIES UAB

Primary DI Number: 04779041940106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 365831125 *Terms of Use

Device Description: The incubator is a new generation of desktop CO2 and O2 incubator used for maintaining an optimal environment for the development of Embryos and Blastocysts.

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
MQG	Accessory, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133742	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: aa48df9a-8ead-4262-a035-c9533f8187f6
Public Version Date: September 14, 2020
Public Version Number: 4
DI Record Publish Date: October 13, 2016