Primary Device ID | 09359921000318 |
NIH Device Record Key | 834f161d-0eed-42c9-8aa7-c0c6e76943c6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Atmo Biosciences |
Version Model Number | 09359921000318 |
Catalog Number | MOB010-0000US |
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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
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 | 09359921000318 [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 |