FDA.report

DeRoyal

Primary DI
50749756045877
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
81-060012
Device description
Esophageal Stethoscope w/o Temperature Sensor
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BZTSTETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS

Product Code Classifications

CodeDeviceSpecialtyClass
BZTStethoscope, Esophageal, With Electrical ConductorsAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50749756045877PackageGS150In Commercial Distribution
00749756045872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975604587750749756045877
00749756045872007497560458727497560458720749756045872

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
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50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50749756392339DeRoyalDEROYAL INDUSTRIES, INC.BZT2023-07-23
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10817499020320NOVATEMPNOVAMED-USA INC.BZT2023-06-27
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10817499020344NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020368NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020375NOVATEMPNOVAMED-USA INC.BZT2023-06-27
10817499020382NOVATEMPNOVAMED-USA INC.BZT2023-06-27
30884521820894Mon-a-ThermCovidien LPBZT2023-05-29
20884521820903Mon-a-ThermCovidien LPBZT2023-05-29
30884521820917Mon-a-ThermCovidien LPBZT2023-05-29
20884521820927Mon-a-ThermCovidien LPBZT2023-05-29
50749756772407DeRoyalDEROYAL INDUSTRIES, INC.BZT2021-07-12
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50749756984060DeRoyalDEROYAL INDUSTRIES, INC.BZT2021-05-07
50749756984190DeRoyalDEROYAL INDUSTRIES, INC.BZT2021-05-07
50749756995554DeRoyalDEROYAL INDUSTRIES, INC.BZT2021-05-07
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00897392002572SourcemarkSOURCEMARK, LLC.BZT2019-02-19
10897392003033Sourcemark SOURCEMARK, LLC.BZT2019-02-19
10897392003040sourcemarkSOURCEMARK, LLC.BZT2019-02-19
00897392002602sourcemarkSOURCEMARK, LLC.BZT2019-02-19