PHCbi - This equipment is designed for providing an - PHC CORPORATION

Duns Number:691795268

Device Description: This equipment is designed for providing an environment with controlled temperature, CO2, 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.

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More Product Details

Catalog Number

-

Brand Name

PHCbi

Version/Model Number

MCO-50M-PA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PUB

Product Code Name

Accessory, Assisted Reproduction, Exempt

Device Record Status

Public Device Record Key

dad8bc09-6576-4552-b7ef-dbac41c62e44

Public Version Date

April 17, 2020

Public Version Number

1

DI Record Publish Date

April 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHC CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16