miniFlow 58422

GUDID 00853678006603

Attachment Strip for bonnets, size 20 cm, single patient use each.

AIRON CORPORATION

CPAP/BPAP nasal mask, single-use

• Primary Device ID: 00853678006603
• NIH Device Record Key: 6ee9e67f-12d6-4502-b3f7-2c621a4b45e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: miniFlow
• Version Model Number: 58422
• Catalog Number: 58422
• Company DUNS: 015222912
• Company Name: AIRON CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 321-821-9433
• Email: info@aironusa.com

Device Dimensions

• Weight: 0.000625 Pound
• Weight: 0.000625 Pound
• Weight: 0.000625 Pound
• Weight: 0.000625 Pound

Operating and Storage Conditions

• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853678006597 [Primary]
GS1	00853678006603 [Package]; Contains: 00853678006597; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121379

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

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: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [miniFlow]

• 00853678006627: Attachment Strip for bonnets, size 23 cm, single patient use each.
• 00853678006603: Attachment Strip for bonnets, size 20 cm, single patient use each.
• 00853678006580: Attachment Strip for bonnets, size 18 cm, single patient use each.
• 00853678006566: Attachment Strip for bonnets, size 15 cm, single patient use each.
• 00853678006542: Attachment Strip for bonnets, size 13 cm, single patient use each.
• 00853678006528: Bonnet, size xxx large, single patient use each.
• 00853678006504: Bonnet, size xx large, single patient use each.
• 00853678006481: Bonnet, size x large, single patient use each.
• 00853678006467: Bonnet, size large, single patient use each.
• 00853678006443: Bonnet, size medium, single patient use each.
• 00853678006429: Bonnet, size small, single patient use each.
• 00853678006405: Bonnet, size x small, single patient use each.
• 00853678006382: miniFlow nCPAP Patient Interface
• 00853678006368: miniFlow Nasal Prongs, size micro, single patient use each.
• 00853678006344: miniFlow Nasal Prongs, size small, single patient use each
• 00853678006320: miniFlow Nasal Prongs, size medium, single patient use each
• 00853678006306: miniFlow Nasal Prongs, size large, single patient use each.
• 00853678006283: miniFlow Nasal Prongs, size x large, single patient use each.
• 00853678006269: miniFlow Nasal Prongs, size wide large, single patient use each.
• 00853678006238: miniFlow Nasal Prongs, size medium wide, single patient use each.
• 00853678006221: miniFlow Nasal Mask, size small, single patient use each.
• 00853678006207: miniFlow Nasal Mask, size medium, single patient use each.
• 00853678006184: miniFlow Nasal Mask, size large, single patient use each.
• 00853678006160: miniFlow Nasal Mask, size x large, single patient use each.