CryoDose H 170294

GUDID 00856331006101

CryoDose H 1 kit w/ 1 canister, 40/ 5mm buds

NUANCE MEDICAL, LLC

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• Primary Device ID: 00856331006101
• NIH Device Record Key: 6038bf95-c56c-49bc-98fa-6fba7480940a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoDose H
• Version Model Number: 170294
• Catalog Number: 170294
• Company DUNS: 078797666
• Company Name: NUANCE MEDICAL, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com
• Phone: +1(760)585-4849
• Email: george@cryodose.com

Device Dimensions

• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter
• Total Volume: 88 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source
• Storage Environment Temperature: Between 0 and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not store near direct heat source

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856331006101 [Primary]

FDA Product Code

• GEH: UNIT, CRYOSURGICAL, ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-03

On-Brand Devices [CryoDose H]

• 00856331006132: CryoDose H 2 canister only
• 00856331006125: CryoDose H 1 canister only
• 00856331006118: CryoDose H 1 kit w/ 1 canister, 20/ 2mm buds, 30/ 5mm buds
• 00856331006101: CryoDose H 1 kit w/ 1 canister, 40/ 5mm buds
• 00856331006095: CryoDose H 1 kit w/ 1 canister, 40/ 2mm buds
• 00856331006088: CryoDose H 1 kit w/ 2 canisters, 30/ 2mm buds, 40/ 5mm buds