Kryo ART Freezer

GUDID B199GDKRYOARTCH161150

Kryo ART Controlled Rate Freezer. 16 litre Chamber Only

PLANER LIMITED

Assisted reproduction freezer

• Primary Device ID: B199GDKRYOARTCH161150
• NIH Device Record Key: 4edefb5d-cc34-40da-b619-d572a10436a2
• Commercial Distribution Discontinuation: 2017-09-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Kryo ART Freezer
• Version Model Number: GDKRYOARTCH-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	B199GDKRYOARTCH161150 [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 ART Freezer]

• B199GDKRYOARTCH331150: Kryo ART Controlled Rate Freezer. 3.3 litre Chamber Only
• B199GDKRYOARTCH171150: Kryo ART Controlled Rate Freezer. 1.7 litre Chamber Only
• B199GDKRYOARTCH161150: Kryo ART Controlled Rate Freezer. 16 litre Chamber Only
• B199GDKRYOART331150: Kryo ART Freezer System. 3.3 Litre Chamber
• B199GDKRYOART171150: Kryo ART Freezer System. 1.7 Litre Chamber
• B199GDKRYOART161150: Kryo ART Controlled Rate Freezer System. 16 Litre Chamber