FDA UDI
In Commercial Distribution
🇺🇸 United States
Avery Breathing Pacemaker System
DI: 00850252006028
·
Model: Neurostimulator Electrode Implant
·
Avery Biomedical Devices Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Avery Breathing Pacemaker System
- Primary DI
- 00850252006028
- Version / Model
- Neurostimulator Electrode Implant
- Catalog Number
- E377-05
- Company Name
- Avery Biomedical Devices Inc
- Labeler DUNS
- 064726441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-01-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 5514810b-792c-450f-8db0-0a08e0515c9b
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GZE | Implanted Diaphragmatic/Phrenic Nerve Stimulator | Neurology | 882.5830 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35652 | Extramuscular 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 an implanted receiver with electrodes that are placed around the patient's phrenic nerve, and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850252006028 | GS1 |
Customer Contacts
- Phone
- 631-864-1600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P860026 | 006 |