FDA UDI
In Commercial Distribution
🇺🇸 United States
Tapscope
DI: 00856233005028
·
Model: 210, single pack
·
CARDIOCOMMAND, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Tapscope
- Primary DI
- 00856233005028
- Version / Model
- 210, single pack
- Catalog Number
- 100
- 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
- fe6285f7-5929-46ec-be56-9a50120eda94
Device Description
10 French esophageal bipolar pacing and recording catheter, (single unit package).
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
- 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 |
|---|---|---|---|---|
| 41474 | Transoesophageal pacing lead | A flexible wire with an electrode, insulated with non-conductive material except at its ends, that serves as an electrical conductor to regulate cardiac pacing, with one end connected to an external temporary pacemaker and the other end (electrode) applied through the oesophagus to the heart. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856233005028 | GS1 | ||||
| Package | 10856233005025 | GS1 | Box of 10 units | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- (800) 231-6370
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P860008 | 017 |
| P860008 | 019 |
| P860008 | 020 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 10 | French |