FDA UDI
In Commercial Distribution
🇺🇸 United States
Tapsystem
DI: 00856233005158
·
Model: 2A re-man'd, unpackaged
·
CARDIOCOMMAND, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tapsystem
- Primary DI
- 00856233005158
- Version / Model
- 2A re-man'd, unpackaged
- Catalog Number
- 8002A-9999
- Company Name
- CARDIOCOMMAND, INC.
- Labeler DUNS
- 800214827
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-22
- Public Version
- 4
- Public Version Date
- 2018-10-05
- Public Version Status
- Update
- Public Device Record Key
- 865465ea-4f70-4f9f-9cd3-3f880ac36d19
Device Description
A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (unpackaged).
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
- Yes
- 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 |
|---|---|---|---|---|
| LPA | System, Esophageal Pacing | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36046 | External pacemaker, transoesophageal pacing | A device designed to generate electrical cardiac pacing impulses from an external pulse generator (EPG), located outside the body, and transmit them to the heart via its leads that are placed in the oesophagus. The device is used for temporary stimulation of the heart. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856233005158 | GS1 |
Customer Contacts
- Phone
- (800) 231-6370
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P840002 | 007 |
| P840002 | 012 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 millibar
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 40 – 158 Degrees Fahrenheit