FDA UDI
In Commercial Distribution
🇺🇸 United States
Renamic Neo
DI: 04035479163068
·
Model: 424723
·
BIOTRONIK SE & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Renamic Neo
- Primary DI
- 04035479163068
- Version / Model
- 424723
- Catalog Number
- 424723
- Company Name
- BIOTRONIK SE & Co. KG
- Labeler DUNS
- 315620229
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-30
- Public Version
- 1
- Public Version Date
- 2021-04-07
- Public Version Status
- New
- Public Device Record Key
- 89405f01-77dd-4d6e-a262-c7cbd6fbd76c
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
- No
- 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 |
|---|---|---|---|---|
| OSR | Pacemaker/icd/crt non-implanted components | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47205 | Cardiac pulse generator programmer | An external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04035479163068 | GS1 |
Customer Contacts
- Phone
- +1(888)345-0374
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P950037 | 213 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 122 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 75 Percent (%) Relative Humidity