FDA UDI
In Commercial Distribution
🇺🇸 United States
Tapscope
DI: 00856233005011
·
Model: 550F, single pack
·
CARDIOCOMMAND, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Tapscope
- Primary DI
- 00856233005011
- Version / Model
- 550F, single pack
- Catalog Number
- 250
- Company Name
- CARDIOCOMMAND, INC.
- Labeler DUNS
- 800214827
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-04-08
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3d29f27a-247b-4dd0-bd50-6653538dcd31
Device Description
18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a female temperature connector, (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 |
|---|---|---|---|---|
| BZT | Stethoscope, Esophageal, With Electrical Conductors | Anesthesiology | 868.1920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44120 | Electronic oesophageal stethoscope, single-use | An electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. Some types may also have a temperature sensor to monitor the patient's temperature. The device will typically contain integral electrical conductors, thermistors/temperature sensors for proximal connection to a patient monitoring device, and include a proximal connector for a standard earpiece. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856233005011 | GS1 | ||||
| Package | 20856233005015 | GS1 | Box of 25 units | 25 | In Commercial Distribution | |
| Package | 10856233005018 | GS1 | Box of 10 units | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- (800) 231-6370
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P860008 | 018 |
| P860008 | 021 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 18 | French |