FDA UDI
In Commercial Distribution
🇺🇸 United States
NeuRx DPS Patient Kit
DI: 00852184003045
·
Model: 20-0036
·
Synapse Biomedical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NeuRx DPS Patient Kit
- Primary DI
- 00852184003045
- Version / Model
- 20-0036
- Company Name
- Synapse Biomedical, Inc.
- Labeler DUNS
- 138432070
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- eebac273-65a7-4a54-a19b-03962d20bb98
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| OIR | Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47808 | Intramuscular diaphragm/phrenic nerve electrical stimulation system | An assembly of battery-powered devices designed to provide ventilatory support to a patient with diaphragm dysfunction of neuromuscular origin through electrical stimulation of the phrenic nerve to contract the diaphragm rhythmically and cause the patient to draw breath in a manner similar to natural breathing. It typically consists of implanted intramuscular electrodes placed in the diaphragm in proximity to the phrenic nerve motor point, an external pulse generator (EPG), and a cable to connect the externally exposed ends of the electrodes with the EPG. The system typically controls parameters such as pulse amplitude, pulse duration, pulse frequency, inspiration time, and respiratory rate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852184003045 | GS1 |