| Primary Device ID | M950503121 | 
| NIH Device Record Key | 5e23b5bd-622f-42b0-a258-5c70d22b249a | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Transcend | 
| Version Model Number | WhisperSoft 4 | 
| Catalog Number | 503121 | 
| Company DUNS | 047069263 | 
| Company Name | SOMNETICS INTERNATIONAL, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | |
| Phone | 8776219626 | 
| info@mytranscend.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | M950503121 [Primary] | 
| BYX | Tubing, Pressure And Accessories | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-08-11 | 
| Device Publish Date | 2022-08-03 | 
| M9505031090 | Filter Assembly | 
| M9505031070 | 3 miniCPAP Service Unit | 
| M9505031060 | 3 miniCPAP System | 
| M9505031050 | 3 miniCPAP Auto Service Unit | 
| M9505031040 | 3 miniCPAP Auto System | 
| M9505031020 | 365 miniCPAP System | 
| M9505031010 | 365 miniCPAP Service Unit | 
| M9505030290 | Mobile Power Adapter | 
| M9505030840 | 3 miniCPAP TranSync Bluetooth Module | 
| M950505030 | AirMist Starter Pack | 
| M950505029 | WhisperSoft Micro 6 | 
| M950505028 | WhisperSoft Micro 4 | 
| M950505027 | AirFlex Micro 4 | 
| M950505026 | WhisperSoft Micro 6 | 
| M950505025 | WhisperSoft Micro 4 | 
| M950505016 | AirMist Cartridges 12 | 
| M950505015 | AirMist Cartridges 8 | 
| M950505014 | AirMist Cartridges 4 | 
| M950505009 | AirMist | 
| M950505004 | AirFlex Micro 6 | 
| M950505003 | WhisperSoft Micro | 
| M950505002 | WhisperSoft | 
| M950503124 | WhisperSoft 6 | 
| M950503123 | WhisperSoft 4 | 
| M950503122 | WhisperSoft 6 | 
| M950503121 | WhisperSoft 4 | 
| M950503120 | AirFlex 6 | 
| M950503119 | AirFlex 4 | 
| M9505030980 | P10 Battery | 
| M9505030260 | P4 Battery | 
| M9505030230 | P8 Battery | 
| M9505050330 | Micro WhisperSoft Muffler - C | 
| M9505050170 | Micro PureFresh | 
| M9505050010 | Micro PowerAway Battery |