FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756045860
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
81-060018
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756045860PackageGS150In Commercial Distribution
00749756045865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975604586050749756045860
00749756045865007497560458657497560458650749756045865

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

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