FDA UDI
In Commercial Distribution
🇺🇸 United States
ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)
DI: 08809308380539
·
Model: B-01
·
REMED Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)
- Primary DI
- 08809308380539
- Version / Model
- B-01
- Company Name
- REMED Co.,Ltd.
- Labeler DUNS
- 688204779
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-05
- Public Version
- 1
- Public Version Date
- 2022-05-13
- Public Version Status
- New
- Public Device Record Key
- 870834e1-7d15-4623-91f0-66700356b3dd
Device Description
ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)_18.8min ver
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | Neurology | 882.5805 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61124 | Magnetic neural stimulation system | An assembly of electrically-powered devices intended for the treatment and/or diagnosis of neurological, psychiatric and/or cognitive conditions (e.g., Alzheimer's disease, major depressive disorder, pain) through noninvasive magnetic stimulation of the brain and/or peripheral nerves. It consists of an electromagnet with a control unit intended to produce electromagnetic field pulses to induce neurological electrical activity, and a patient chair; types intended for transcranial magnetic stimulation (TMS) may include cognitive training tools. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809308380539 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220625 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius