Direct Heat CO2 Incubator
Thermo Scientific Forma - 351
Device Description
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.
Environmental Conditions
- Indoor use only
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MQG
Device Name: Accessory, Assisted Reproduction
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OB
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 884.6120
Third Party Flag: Y
Medical Specialty: OB
Device IdentifiersDevice Id: 10815773020059
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A