FDA.reportPublic FDA data

Tapscope

Primary DI
00856233005004
Brand
Tapscope
Company
CARDIOCOMMAND, INC.
Model
550, single pack
Catalog number
200
Device description
18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a male temperature connector, (single unit package).
Published
2015-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZTStethoscope, Esophageal, With Electrical Conductors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZTStethoscope, Esophageal, With Electrical ConductorsAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P860008018
P860008021

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P860008018ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7Cardio Command1986-12-30LPA
P860008021ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7Cardio Command1986-12-30LPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856233005001PackageGS110In Commercial Distribution
20856233005008PackageGS125In Commercial Distribution
00856233005004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085623300500110856233005001
2085623300500820856233005008
00856233005004008562330050048562330050040856233005004

GMDN Terms#

Term, Definition table
TermDefinition
Electronic oesophageal stethoscope, single-useAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge18French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 231-6370cconley@CardioCommand.com

Regulatory Flags#

DUNS number
800214827
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856233005127Model 7ALeft arm patient lead wire80212015-04-03
00856233005134Model 7ARight arm patient lead wire80232015-04-03
10856233005063Tapsystem2A, single pack8002A2015-07-22
10856233005155Tapsystem2A re-man'd, single pack8002A-99992015-07-22
10856233005162Model 7ASingle pack01012015-04-03
10856233005179Model 7ARe-manufactured, single pack0101-99992015-04-03
00856233005066Tapsystem2A, unpackaged8002A2015-07-22
00856233005110Model 7A7A/Mod 3 Interface cable04062015-04-03
00856233005158Tapsystem2A re-man'd, unpackaged8002A-99992015-07-22
00856233005165Model 7AUnpackaged01012015-04-03
00856233005172Model 7ARe-manufactured, unpackaged0101-99992015-04-03
10856233005186Model 3Single pack01042015-04-03
10856233005193Model 3Re-manufactured, single pack0104-99992015-04-03
00856233005011Tapscope550F, single pack2502015-04-08
00856233005028Tapscope210, single pack1002015-04-03
00856233005035Tapscope210-S, single pack1022015-04-03
00856233005042Tapcath205, single pack1802015-04-03
00856233005059Tapcath1600, single pack16002015-07-22
00856233005073Tapsystem2A Patient Cable20102015-07-22
00856233005080EP ConnectTapcath8031-00012015-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756392334DeRoyalDEROYAL INDUSTRIES, INC.BZT2023-07-23
50749756392339DeRoyalDEROYAL INDUSTRIES, INC.BZT2023-07-23
00817499020101LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
00817499020286LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
00817499020293LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
00817499020309LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
00817499020316NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020323NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020330NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020347NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020361NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020378NOVATEMPNOVAMED-USA INC.BZT2023-06-27
00817499020385NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020108LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
10817499020283LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
10817499020290LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
10817499020306LIFESOUNDNOVAMED-USA INC.BZT2023-06-27
10817499020313NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020320NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020337NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020344NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020368NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020375NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020382NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10884521820890Mon-a-ThermCovidien LPBZT2023-05-29
10884521820906Mon-a-ThermCovidien LPBZT2023-05-29
10884521820913Mon-a-ThermCovidien LPBZT2023-05-29
10884521820920Mon-a-ThermCovidien LPBZT2023-05-29
30884521820894Mon-a-ThermCovidien LPBZT2023-05-29
20884521820903Mon-a-ThermCovidien LPBZT2023-05-29