FDA UDI
In Commercial Distribution
🇺🇸 United States
Atmo Biosciences
DI: 09359921000172
·
Model: 09359921000172
·
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
- 09359921000172
- Version / Model
- 09359921000172
- Catalog Number
- PWR010-0000US
- 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
- 5d36d028-1555-44dd-85d2-52a4465d726d
Device Description
Power Supply: A component of the Atmo Gas Capsule System used to charge the Receiver and Mobile Device.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 36545 | Basic power supply, reusable | A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09359921000172 | GS1 |
Customer Contacts
- Phone
- +1 (612) 429-6279
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250940 | 000 |