FDA UDI
In Commercial Distribution
🇺🇸 United States
DH
DI: 04035479144807
·
Model: 331668
·
BIOTRONIK SE & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
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Basic Information
- Brand Name
- DH
- Primary DI
- 04035479144807
- Version / Model
- 331668
- Catalog Number
- 331668
- Company Name
- BIOTRONIK SE & Co. KG
- Labeler DUNS
- 315620229
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2014-08-14
- Public Version
- 5
- Public Version Date
- 2024-03-20
- Public Version Status
- Update
- Public Device Record Key
- 07a01401-a66c-46e3-bf67-c1c906af521d
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NVN | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35223 | Endocardial/interventricular septal pacing lead | An implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04035479044510 | GS1 | case | 5 | In Commercial Distribution | |
| Primary | 04035479144807 | GS1 | ||||
| Unit of Use | 04035479147068 | GS1 |
Customer Contacts
- Phone
- +1(888)345-0374
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P950037 | 034 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Type
- Storage Environment Temperature
- Temperature Range
- 41 – 131 Degrees Fahrenheit