FDA UDI
In Commercial Distribution
🇺🇸 United States
EP Connect
DI: 00856233005080
·
Model: Tapcath
·
CARDIOCOMMAND, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EP Connect
- Primary DI
- 00856233005080
- Version / Model
- Tapcath
- Catalog Number
- 8031-0001
- Company Name
- CARDIOCOMMAND, INC.
- Labeler DUNS
- 800214827
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-04-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3d2f9cd7-9438-4e12-a3f0-657091a9d0fd
Device Description
A 10 ft. cable that connects Tapcath catheter products to ECG recorders using a modular to pin connector. .
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | 870.1220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47483 | Electrocardiographic lead/catheter adaptor | A small, sterile, connecting device that enables a mechanical union between an in situ cardiac catheter [e.g., an electrophysiology (EP) diagnostic catheter] and an electrocardiograph (ECG) cable/lead for transmission of heart signals to an ECG machine. This device allows the connection of the otherwise incompatible connectors of the cardiac catheter to a standard ECG cable/lead or a cable/lead of different manufacture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856233005080 | GS1 |
Customer Contacts
- Phone
- (800) 231-6370
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P860008 | 017 |
| P860008 | 019 |
| P860008 | 020 |