Hydrozid

GUDID 05744002420033

Hydrozid, portable cryosurgery device, 200mL

Bibawo Medical A/S

Cryogenic spray, cutaneous

• Primary Device ID: 05744002420033
• NIH Device Record Key: c60d380b-4686-4bfa-9402-733b550189e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrozid
• Version Model Number: 101
• Company DUNS: 306164504
• Company Name: Bibawo Medical A/S
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter
• Total Volume: 200 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *store upright
• Special Storage Condition, Specify: Between 0 and 0 *Store out of direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	05744002420033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201740

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13