Salter AIRE Elite SO-1648GN
GUDID 00607411201165
Salter AIRE Elite Compressor with Nebulizer
SALTER LABS
Nebulizing system, non-heated| Primary Device ID | 00607411201165 |
| NIH Device Record Key | 1656ecf1-02ec-485b-84b2-ea95afb99b80 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Salter AIRE Elite |
| Version Model Number | SO-1648GN |
| Catalog Number | SO-1648GN |
| Company DUNS | 022721133 |
| Company Name | SALTER LABS |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com | |
| Phone | +1(800)421-0024 |
| customercare@salterlabs.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00607411201165 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K962879
FDA Product Code
| CAF | NEBULIZER (DIRECT PATIENT INTERFACE) |
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 [Salter AIRE Elite]
| 00607411918391 | Compressor with Nebulizers 8660, Carry bag 8258 and Ped Aero Mask 1120 |
| 00607411918360 | Salter AIRE Elite Compressor with Nebulizers (2) 8960 |
| 00607411918346 | Compressor with (1) 8900 Nebulizer |
| 00607411915826 | Equipment Salter AIRE Elitte Compressor with Nebulizer |
| 00607411915666 | Compressor with Nebulizer No. 8900 |
| 00607411893759 | Salter AIRE Elite Compressor with Nebulizers and DVD |
| 00607411891489 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411891328 | Salter AIRE Elite Compressor with Nebulizer and DVD |
| 00607411891274 | Hartman Brothers Salter AIRE Elite Compressor with Nebulizer |
| 00607411889523 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411889363 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411889356 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411889158 | Manchester & Souther NH Salter AIRE Elite |
| 00607411801297 | Compressor with Nebulizers (2) 8660 |
| 00607411801266 | Equipment Salter & Rentals Salter AIRE Elite |
| 00607411801259 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411801242 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411801167 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411801150 | Salter AIRE Elite Compressor with NebuTech HDN Nebulizer |
| 00607411801129 | Salter Air Elite® with Nebulizer. |
| 00607411300394 | Compressor with Nebulizers (1) 8900 and (1) 8660 Obsolete |
| 00607411201172 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411201165 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411102158 | Salter AIRE Elite® with Nebulizer. |
| 00607411102103 | Salter Air Elite® with Nebulizer. |
| 00607411007873 | Compressor with Nebulizer (1) 8900 |
| 00607411007859 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411007804 | Compressor with Nebulizer (1) 8900 & Carry Bag (1) 8258 |
| 00607411007750 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411007736 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411007521 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411007392 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411007385 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411007231 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411006661 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411006036 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411005893 | Comrpessor with Nebulizer and Carry Bag |
| 00607411005336 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411005312 | Oxygen Elite Salter AIRE :Elite Compressor with Nebulizer |
| 00607411005282 | Grandview Medical Salter AIRE Elite Compressor w Nebulizer (1) 8900 |
| 00607411005275 | Salter AIRE Elite Compressor with Nebulizer (1) 8900 and (1) 8660 Nebulizers |
| 00607411005268 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411005244 | Oxygen Salter AIRE Elite Compressor with Nebulizer |
| 00607411005237 | 8660 & 8900 w instructional DVD |
| 00607411005213 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411005169 | Salter AIRE Elite Compressor with Nebulizer Obsolete |
| 00607411005152 | Salter AIRE Elite Compressor with Nebulizer |
| 00607411005091 | Salter AIRE Elite Compressor with Nebulizer and Carry Bag |
| 00607411005077 | Rehabilitation Equipment Salter Aire Elite |
| 00607411005046 | Salter AIRE Elite Compressor with Nebulizer |
Trademark Results [Salter AIRE Elite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SALTER AIRE ELITE 86273934 4765754 Live/Registered |
SALTER LABS, LLC 2014-05-07 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.