MACS 58011
GUDID 00853678006085
Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long with large mask and head strap each.
AIRON CORPORATION
Anaesthesia breathing circuit, single-use| Primary Device ID | 00853678006085 |
| NIH Device Record Key | 38a38c35-2bb7-47f7-b017-0d9099f2a0a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MACS |
| Version Model Number | 58011 |
| Catalog Number | 58011 |
| 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 | true |
| Single Use | true |
| 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 | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com | |
| Phone | 3218219433 |
| info@aironusa.com |
Device Dimensions
| Weight | 0.3125 Pound |
| Weight | 0.3125 Pound |
| Weight | 0.3125 Pound |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
| Length | 72 Inch |
| Width | 0.86 Inch |
| Height | 0.86 Inch |
| Weight | 0.3125 Pound |
Operating and Storage Conditions
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -15 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853678006078 [Primary] |
| GS1 | 00853678006085 [Package] Contains: 00853678006078 Package: box [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080692
FDA Product Code
| BTL | Ventilator, Emergency, Powered (Resuscitator) |
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 | 2019-11-27 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [MACS]
| 00853678006665 | Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long, with large m |
| 00853678006085 | Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long with large ma |
| 00853678006047 | MACS epic CPAP System |
| 00853678006030 | MACS CPAP System |
Trademark Results [MACS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MACS 97408329 not registered Live/Pending |
SANFORD, JANMARCA 2022-05-12 |
MACS 97408329 not registered Live/Pending |
CASTELLANOS, JENNEXIS 2022-05-12 |
 MACS 90539139 not registered Live/Pending |
LivePerson, Inc. 2021-02-22 |
 MACS 88437891 5936493 Live/Registered |
Martial Arts City Supplies Inc. 2019-05-20 |
 MACS 86249670 4813884 Live/Registered |
Familyland Enterprises, LLC 2014-04-11 |
 MACS 85420289 not registered Dead/Abandoned |
LENSTEC, INC. 2011-09-12 |
 MACS 79190658 5163620 Live/Registered |
MACS Maritime Carrier Shipping GmbH & Co. 2015-12-14 |
 MACS 79184396 5153199 Live/Registered |
MACS Maritime Carrier Shipping GmbH & Co. 2015-12-14 |
 MACS 79152214 4853118 Live/Registered |
Miltenyi Biotec B.V. & Co. KG 2014-03-14 |
 MACS 78967890 3455841 Dead/Cancelled |
Alternative Design Manufacturing and Supply, Inc. 2006-09-06 |
 MACS 78532549 3028877 Dead/Cancelled |
Mobile Access Communications Services, Inc. 2004-12-14 |
 MACS 78517428 not registered Dead/Abandoned |
Andrx Pharmaceuticals, LLC 2004-11-16 |
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