FDA UDI
In Commercial Distribution
🇺🇸 United States
REAL Immersive System
DI: 00815948024229
·
Model: RLE1-A
·
PENUMBRA, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- REAL Immersive System
- Primary DI
- 00815948024229
- Version / Model
- RLE1-A
- Company Name
- PENUMBRA, INC.
- Labeler DUNS
- 191077671
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-14
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 9348f3dd-1124-4d93-96f3-628dbc1a4a51
Device Description
REAL i-Series
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| PWC | General Wellness Product | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65220 | Mindfulness/behavioural therapy software, non-clinician-consultative | A software program intended to be used with an off-the-shelf computer/tablet/smartphone to help treat affective/mood disorders, stress, and/or other disorders related to or caused by these, by providing a patient with on-screen therapeutic exercises (e.g., mindfulness, mental imagery, cognitive behavioural therapy) often with educational information; it is not dedicated to exposure therapy. It is intended for use by a patient at home and is not based on consultation with a clinician. | No | Obsolete |
| 65392 | Mental health/function therapeutic software, virtual reality | A virtual reality software program intended to be used with an off-the-shelf device in conjunction with a virtual reality headset (not included) to help improve mental health/wellbeing (e.g., control effects of mood disorders, stress) and/or a cognitive function (e.g., attention/concentration, reading ability) by providing a patient with an interactive, immersive game; it is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient at home, school, and in clinical settings in conjunction with clinician consultation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815948024229 | GS1 |