Kryo 360 Freezer

GUDID B199GDKRYO360CH171150

Kryo 360 Controller Rate Freezer - 1.7 Chamber Only

PLANER LIMITED

Assisted reproduction freezer

• Primary Device ID: B199GDKRYO360CH171150
• NIH Device Record Key: 9ff14594-da35-42a7-ac92-279a1bafec9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kryo 360 Freezer
• Version Model Number: GDKRYO360CH-1.7-115
• Company DUNS: 217190495
• Company Name: PLANER LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B199GDKRYO360CH171150 [Primary]

FDA Product Code

• MQG: Accessory, Assisted Reproduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-28
• Device Publish Date: 2016-09-23

On-Brand Devices [Kryo 360 Freezer]

• B199GDKRYO360CH331150: Kryo 360 Controlled Rate Freezer. 3.3 litre Chamber Only
• B199GDKRYO360CH171150: Kryo 360 Controller Rate Freezer - 1.7 Chamber Only
• B199GDKRYO36033115DT0: Kryo 360 Controlled Rate Freezer. 3.3 Litre Chamber.
• B199GDKRYO360331150: Kryo 360 Controlled Rate Freezer. 3.3 Litre Chamber
• B199GDKRYO36017115DT0: Kryo 360 Controlled Rate Freezer. 1.7 Litre Chamber
• B199GDKRYO360171150: Kryo 360 Controlled Rate Freezer. 1.7 Litre Chamber