AirLife FC0010
GUDID 30889483631472
AirLife Sterile Water for Inhalation, USP 1000ml with Spikeable Cap and Hanger
SUNMED, LLC
Inhalation therapy sterile water| Primary Device ID | 30889483631472 |
| NIH Device Record Key | e3927803-c9c1-4f9a-9ae5-9b148cfdc8d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AirLife |
| Version Model Number | FC0010 |
| Catalog Number | FC0010 |
| Company DUNS | 069009268 |
| Company Name | SUNMED, LLC |
| 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 | 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 | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com | |
| Phone | 1-800-433-2797 |
| info@sun-med.com |
Device Dimensions
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
| Total Volume | 1000 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889483631478 [Primary] |
| GS1 | 30889483631472 [Package] Contains: 10889483631478 Package: Box [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223551
FDA Product Code
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-09 |
| Device Publish Date | 2026-02-27 |
Devices Manufactured by SUNMED, LLC
| 30889483631472 - AirLife | 2026-03-09AirLife Sterile Water for Inhalation, USP 1000ml with Spikeable Cap and Hanger |
| 30889483631472 - AirLife | 2026-03-09 AirLife Sterile Water for Inhalation, USP 1000ml with Spikeable Cap and Hanger |
| 20889483033309 - SunMed | 2026-02-26 SunSlip Sheath Stylette - Infant |
| 20889483033316 - SunMed | 2026-02-26 SunSlip Sheath Stylette - Child |
| 20889483033323 - SunMed | 2026-02-26 SunSlip Sheath Stylette - Adult |
| 20889483230005 - VixOne™ | 2026-02-19 VixOne™ Nebulizer Mask Kit, Pediatric |
| 20889483300135 - Respan® | 2026-02-19 Disposable Anesthesia Breathing Circuit, 60" Adult Circuit, Parallel Wye, Gas Sampling Elbow |
| 30889483562615 - BALLARD™ | 2026-02-06 BALLARD™ TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, Double Swivel Elbow, Endotracheal |
| 30889483563391 - BALLARD™ | 2026-02-06 BALLARD™ ORAL CARE SUCTION CATHETER FOR ADULTS |
Trademark Results [AirLife]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AIRLIFE 97938590 not registered Live/Pending |
SunMed Group Holdings, LLC 2023-05-16 |
 AIRLIFE 97553332 not registered Live/Pending |
Hudson Brands, Inc. 2022-08-17 |
 AIRLIFE 86148589 not registered Dead/Abandoned |
Techtronic Floor Care Technology Limited 2013-12-19 |
 AIRLIFE 85669918 not registered Dead/Abandoned |
AIRLIFE CHILE S.A. 2012-07-06 |
 AIRLIFE 85253709 4335355 Dead/Cancelled |
AIRLIFE CHILE S.A. 2011-02-28 |
 AIRLIFE 79309660 not registered Live/Pending |
FINAL SPOR VE TEKSTIL SANAYI VE TICARETLIMITED SIRKETI 2020-08-12 |
 AIRLIFE 79210163 not registered Dead/Abandoned |
FINAL SPOR VE TEKSTIL SANAYI VE TICARETLIMITED SIRKETI 2016-10-18 |
 AIRLIFE 78545378 3150546 Live/Registered |
CAREFUSION 2200, INC. 2005-01-11 |
 AIRLIFE 78534814 3111371 Dead/Cancelled |
HENKEL AG & CO. KGAA 2004-12-17 |
 AIRLIFE 77830202 not registered Dead/Abandoned |
Hewlett-Packard Development Company, L.P. 2009-09-18 |
 AIRLIFE 75926229 not registered Dead/Abandoned |
AirSep Corporation 2000-02-23 |
 AIRLIFE 73353790 not registered Dead/Abandoned |
Insurance Concepts, Inc. 1982-03-10 |
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