DEVICE: Tapscope (00856233005011)

Device Identifier (DI) Information

Tapscope
550F, single pack
In Commercial Distribution
250
CARDIOCOMMAND, INC.
00856233005011
GS1

1
800214827 *Terms of Use
18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a female temperature connector, (single unit package).
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
BZT Stethoscope, Esophageal, With Electrical Conductors
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P860008 018
P860008 021
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Catheter Gauge: 18 French
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Device Record Status

3d29f27a-247b-4dd0-bd50-6653538dcd31
July 06, 2018
3
April 08, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20856233005015 25 00856233005011 In Commercial Distribution Box of 25 units
10856233005018 10 00856233005011 In Commercial Distribution Box of 10 units
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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(800) 231-6370
cconley@CardioCommand.com
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