AccessGUDID - DEVICE: Panasonic (04987905300045)

GUDID

Device Identifier (DI) Information

Brand Name: Panasonic
Version or Model: MCO-170AICUV-PA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PHC CORPORATION

Primary DI Number: 04987905300045
Issuing Agency: GS1
Commercial Distribution End Date: October 16, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 691795268 *Terms of Use

Device Description: This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.

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?
40520	Carbon dioxide laboratory incubator	A mains electricity (AC-powered) incubator in which a fixed temperature and carbon dioxide (CO2) controlled conditions can be achieved and maintained. It is used for the incubation of biological and chemical materials. The percentage mixture of carbon dioxide and other gases, typically oxygen, can be different depending on the use and device type.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQG	Accessory, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: ae5fc542-e8ff-4302-af21-d4e8e5cbc6d2
Public Version Date: January 11, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016