| Primary Device ID | 09359921000004 |
| NIH Device Record Key | 22c7a4c2-0343-4d8c-921e-1f9bf6a3405e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Atmo Biosciences |
| Version Model Number | 09359921000004 |
| Catalog Number | CBL010-0000ZZ |
| Company DUNS | 745092519 |
| Company Name | ATMO BIOSCIENCES LIMITED |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | +1 (612) 429-6279 |
| cs@atmobiosciences.com | |
| Phone | +1 (612) 429-6279 |
| cs@atmobiosciences.com | |
| Phone | +1 (612) 429-6279 |
| cs@atmobiosciences.com | |
| Phone | +1 (612) 429-6279 |
| cs@atmobiosciences.com | |
| Phone | +1 (612) 429-6279 |
| cs@atmobiosciences.com | |
| Phone | +1 (612) 429-6279 |
| cs@atmobiosciences.com | |
| Phone | +1 (612) 429-6279 |
| cs@atmobiosciences.com | |
| Phone | +1 (612) 429-6279 |
| cs@atmobiosciences.com | |
| Phone | +1 (612) 429-6279 |
| cs@atmobiosciences.com | |
| Phone | +1 (612) 429-6279 |
| cs@atmobiosciences.com | |
| Phone | +1 (612) 429-6279 |
| cs@atmobiosciences.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09359921000004 [Primary] |
| NYV | Gastrointestinal Motility System, Capsule |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-13 |
| Device Publish Date | 2025-08-05 |
| 09359921000318 | Mobile Device: A component of the Atmo Gas Capsule System used to initiate a study and upload th |
| 09359921000202 | Atmo Gas Capsule (Capsule): The ingestible component of the Atmo Gas Capsule System with onboard |
| 09359921000172 | Power Supply: A component of the Atmo Gas Capsule System used to charge the Receiver and Mobile |
| 09359921000141 | Data Receiver (Receiver): A component of the Atmo Gas Capsule System designed to receive and sto |
| 09359921000004 | USB Cable: A component of the Atmo Gas Capsule System that connects the Mobile Device to the Rec |