Kryo ART Freezer

Basic Information

• Brand Name: Kryo ART Freezer
• Primary DI: B199GDKRYOART331150
• Version / Model: GDKRYOART-3.3-115
• Company Name: PLANER LIMITED
• Labeler DUNS: 217190495
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2019-10-28
• Public Version Status: Update
• Public Device Record Key: b698a37e-8ab3-4b7c-a40b-17dc0e001997
• Distribution End Date: 2017-09-13

Device Description

Kryo ART Freezer System. 3.3 Litre Chamber

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	884.6120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35829	Freezer control unit, programmable	A mains electricity (AC-powered) unit used together with a specific freezer where it is important that a certain predetermined freezing pattern is followed in order to preserve the contents of the freezer. This pattern may differ according to various considerations, e.g., lowering of temperature by steps over a given time. A pre-set program will be imposed upon the freezer.	No	Active
44622	Assisted reproduction freezer	A mains electricity (AC-powered) device designed to provide suitable cold storage conditions for reproductive biological materials (e.g., gametes, embryos) at closely regulated and monitored temperatures. It will typically use liquid nitrogen (LN2) to create cold temperatures, as well as an electrical heater and air circulating fan for temperature control. It will typically have an integral alarm system to warn against temperature variations and breaks in the mains power supply. This device is typically not intended for long-term storage.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B199GDKRYOART331150	HIBCC

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 5 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius