FDA.reportPublic FDA data

NOVATEMP

Primary DI
10817499020382
Brand
NOVATEMP
Company
NOVAMED-USA INC.
Model
10-1620-001
Device description
12FR esophageal/rectal temperature probe/400 series sterile - each
Published
2023-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10817499020382PackageGS140In Commercial Distribution
20817499020389PackageGS14In Commercial Distribution
00817499020385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081749902038210817499020382
2081749902038920817499020389
00817499020385008174990203858174990203850817499020385

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, single-useA temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
914-789-2100info@novamed-usa.com

Regulatory Flags#

DUNS number
831531426
Device count
1
DM exempt
false
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
00817499020859NOVALITE18-600SMH2023-06-28
00817499020866NOVALITE18-600SPH2023-06-28
00817499020873NOVALITE18-600SSH2023-06-28
00817499020453NOVATEMP11-CA-400-122023-06-28
00817499020460NOVATEMP11-CA-400-202023-06-28
00817499020477NOVATEMP11-CA-401-122023-06-28
00817499020484NOVATEMP11-CA-401-202023-06-28
00817499020491NOVATEMP11-CA-402-102023-06-28
00817499020507NOVATEMP11-CA-402-122023-06-28
00817499020514NOVATEMP11-CA-402-202023-06-28
00817499020521NOVATEMP11-CA-403-122023-06-28
00817499020538NOVATEMP11-CA-404-122023-06-28
00817499020545NOVATEMP11-CA-404-202023-06-28
00817499020552NOVATEMP11-CA-405-122023-06-28
00817499020569NOVATEMP11-CA-407-042023-06-28
00817499020576NOVATEMP11-CA-407-122023-06-28
10817499020856NOVALITE18-600SMH2023-06-28
10817499020863NOVALITE18-600SPH2023-06-28
10817499020870NOVALITE18-600SSH2023-06-28
00817499020880NOVALITE14-600S-012023-06-28

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
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
30884521820917Mon-a-ThermCovidien LPBZT2023-05-29