Kryo 560 Freezer

GUDID B199GDKRYO560CH161150

Kryo 560 Controlled Rate Freezer - 16 LItre Chamber Only

PLANER LIMITED

Assisted reproduction freezer

• Primary Device ID: B199GDKRYO560CH161150
• NIH Device Record Key: b97da059-2ab6-440c-aab3-8dc2b29cacdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kryo 560 Freezer
• Version Model Number: GDKRYO560CH-16-115
• 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	B199GDKRYO560CH161150 [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 560 Freezer]

• B199GDKRYO560CH161150: Kryo 560 Controlled Rate Freezer - 16 LItre Chamber Only
• B199GDKRYO56016155DT0: Kryo 560 Controlled Rate Freezer. 16 Litre Chamber
• B199GDKRYO560161150: Kryo 560 Controlled Rate Freezer. 16 Litre Chamber