FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756045841
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
81-070009
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
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
50749756045846PackageGS150In Commercial Distribution
00749756045841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975604584650749756045846
00749756045841007497560458417497560458410749756045841

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.

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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