FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TB
DI: 00836559009740
·
Model: 020006
·
Oscor Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TB
- Primary DI
- 00836559009740
- Version / Model
- 020006
- Catalog Number
- 020006
- Company Name
- Oscor Inc.
- Labeler DUNS
- 101835833
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 5
- Public Version Date
- 2020-07-24
- Public Version Status
- Update
- Public Device Record Key
- 8f5e1fb2-b20f-45a1-ab94-f2a2a5cc8b2e
- Distribution End Date
- 2018-08-14
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
- Yes
- 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 |
|---|---|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | Cardiovascular | 870.3680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47311 | Atrial cardioversion system catheter | A sterile, thin, flexible tube that interfaces proximally with an electrocardiogram (ECG) monitor/recorder and defibrillator, and distally with the myocardium, for electrical cardioversion (CV) to treat atrial tachyarrhythmias [e.g., atrial fibrillation (AF)]. It typically has multiple lumens with specific functions (e.g., for various electrode arrays, guidewire, air) and may be balloon-tipped to facilitate transvenous placement; it may have sensing, pacing, and pressure measurement capabilities. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00836559009740 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K861403 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius