FDA UDI
In Commercial Distribution
🇺🇸 United States
Durata™
DI: 05414734502139
·
Model: 7121/75
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Durata™
- Primary DI
- 05414734502139
- Version / Model
- 7121/75
- Catalog Number
- 7121/75
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 790268031
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-02
- Public Version
- 5
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 250b84c8-9f44-4b60-b428-8de9e37924cd
Device Description
Defibrillation Lead
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWS | Implantable cardioverter defibrillator (non-CRT) | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35853 | Endocardial defibrillation lead | An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05414734502139 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P950022 | 049 |
| P950022 | 110 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 75 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temp. from 68-77°F (20-25°C). Excursions permitted from 59-86°F (15-30°C). During Trans/Handling excursions allowed between 23-122°F (-5-50°C) <24 hours.
- Type
- Storage Environment Temperature
- Temperature Range
- 68 – 77 Degrees Fahrenheit