Hydrozid

GUDID 05744002420033

Hydrozid, portable cryosurgery device, 200mL

Bibawo Medical A/S

Cryogenic spray, cutaneous Cryogenic spray, cutaneous Cryogenic spray, cutaneous Cryogenic spray, cutaneous Cryogenic spray, cutaneous Cryogenic spray, cutaneous Cryogenic spray, cutaneous Cryogenic spray, cutaneous Cryogenic spray, cutaneous Cryogenic spray, cutaneous Cryogenic spray, cutaneous Cryogenic spray, cutaneous Cryogenic spray, cutaneous Cryogenic spray, cutaneous Cryogenic spray, cutaneous 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