miniFlow 58405
GUDID 00853678006283
miniFlow Nasal Prongs, size x large, single patient use each.
AIRON CORPORATION
CPAP nasal oxygen cannula| Primary Device ID | 00853678006283 |
| NIH Device Record Key | e58dec0d-cb51-460f-a85a-70310e7982d7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | miniFlow |
| Version Model Number | 58405 |
| Catalog Number | 58405 |
| 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 |
| info@aironusa.com | |
| Phone | 321-821-9433 |
| info@aironusa.com | |
| Phone | 321-821-9433 |
| info@aironusa.com | |
| Phone | 321-821-9433 |
| info@aironusa.com | |
| Phone | 321-821-9433 |
| info@aironusa.com | |
| Phone | 321-821-9433 |
| info@aironusa.com | |
| Phone | 321-821-9433 |
| info@aironusa.com | |
| Phone | 321-821-9433 |
| info@aironusa.com | |
| Phone | 321-821-9433 |
| info@aironusa.com | |
| Phone | 321-821-9433 |
| info@aironusa.com | |
| Phone | 321-821-9433 |
| info@aironusa.com | |
| Phone | 321-821-9433 |
| info@aironusa.com | |
| Phone | 321-821-9433 |
| info@aironusa.com | |
| Phone | 321-821-9433 |
| info@aironusa.com |
Device Dimensions
| Weight | 0.021 Pound |
| Weight | 0.021 Pound |
| Weight | 0.021 Pound |
| Weight | 0.021 Pound |
| Height | 0.5 Inch |
| Width | 0.25 Inch |
| Length | 2 Inch |
| Weight | 0.021 Pound |
| Height | 0.5 Inch |
| Width | 0.25 Inch |
| Length | 2 Inch |
| Weight | 0.021 Pound |
| Height | 0.5 Inch |
| Width | 0.25 Inch |
| Length | 2 Inch |
| Weight | 0.021 Pound |
| Height | 0.5 Inch |
| Width | 0.25 Inch |
| Length | 2 Inch |
| Weight | 0.021 Pound |
| Height | 0.5 Inch |
| Width | 0.25 Inch |
| Length | 2 Inch |
| Weight | 0.021 Pound |
| Height | 0.5 Inch |
| Width | 0.25 Inch |
| Length | 2 Inch |
| Weight | 0.021 Pound |
| Height | 0.5 Inch |
| Width | 0.25 Inch |
| Length | 2 Inch |
| Weight | 0.021 Pound |
| Height | 0.5 Inch |
| Width | 0.25 Inch |
| Length | 2 Inch |
| Weight | 0.021 Pound |
| Height | 0.5 Inch |
| Width | 0.25 Inch |
| Length | 2 Inch |
| Weight | 0.021 Pound |
| Height | 0.5 Inch |
| Width | 0.25 Inch |
| Length | 2 Inch |
| Weight | 0.021 Pound |
| Height | 0.5 Inch |
| Width | 0.25 Inch |
| Length | 2 Inch |
| Weight | 0.021 Pound |
| Height | 0.5 Inch |
| Width | 0.25 Inch |
| Length | 2 Inch |
| Weight | 0.021 Pound |
| Height | 0.5 Inch |
| Width | 0.25 Inch |
| Length | 2 Inch |
| Weight | 0.021 Pound |
Operating and Storage Conditions
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853678006276 [Primary] |
| GS1 | 00853678006283 [Package] Contains: 00853678006276 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 | 4 |
| Public Version Date | 2018-12-21 |
| 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. |
Trademark Results [miniFlow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MINIFLOW 79036194 3352731 Dead/Cancelled |
HORIBA, Ltd. 2007-01-22 |
 MINIFLOW 75102798 not registered Dead/Abandoned |
Madison Group: PPRC, The 1996-05-13 |
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