FDA UDI
In Commercial Distribution
🇺🇸 United States
Atmo Biosciences
DI: 09359921000318
·
Model: 09359921000318
·
ATMO BIOSCIENCES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Atmo Biosciences
- Primary DI
- 09359921000318
- Version / Model
- 09359921000318
- Catalog Number
- MOB010-0000US
- Company Name
- ATMO BIOSCIENCES LIMITED
- Labeler DUNS
- 745092519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-05
- Public Version
- 1
- Public Version Date
- 2025-08-13
- Public Version Status
- New
- Public Device Record Key
- 834f161d-0eed-42c9-8aa7-c0c6e76943c6
Device Description
Mobile Device: A component of the Atmo Gas Capsule System used to initiate a study and upload the results via the Clinic App.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NYV | Gastrointestinal Motility System, Capsule | Gastroenterology, Urology | 876.1725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64248 | Panel computer | A non-dedicated, electrically-powered, compact computer unit with an integrated touchscreen monitor designed to be used in a mobile platform (e.g., mounted on a stand, mount, pole, laboratory equipment). It is typically made of or coated with an antimicrobial material to prevent cross-contamination in a medical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09359921000318 | GS1 |
Customer Contacts
- Phone
- +1 (612) 429-6279
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250940 | 000 |