FDA.reportPublic FDA data

AccuTemp Probe

Primary DI
10817522010212
Brand
AccuTemp Probe
Company
KENTEC MEDICAL, INC.
Model
230H
Catalog number
230H
Device description
ACCU-TEMP PROBE #230 FOR USE W/OHMEDAw/hydrogel 175 probe cover
Published
2016-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMTWarmer, Infant Radiant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMTWarmer, Infant RadiantGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960080000ACCUTEMP PROBEKentec Medical, Inc.1996-05-01FMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817522010219PackageGS110In Commercial Distribution
10817522010212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081752201021920817522010219
1081752201021210817522010212

GMDN Terms#

Term, Definition table
TermDefinition
Environmental sensorAn electronic device designed to be used to monitor the conditions of a specific environment. It may be used to monitor environmental parameters such as air temperature, relative humidity, or atmospheric oxygen concentration. This device, designed as a cable/lead with a sensor at the distal end and a connecting plug (e.g., a jack plug) at its proximal end, is used with a parent device that requires environmental monitoring, e.g., an infant incubator, or with a dedicated monitoring device.

Contacts#

Phone, Email table
PhoneEmail
949-863-0810kjrooks@kentecmedical.com

Regulatory Flags#

DUNS number
066175613
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817522010250Kentec ArmBoard403AB403AB2021-12-16
10817522010267Kentec ArmBoard403ABV403ABV2021-12-16
10817522010298Kentec ArmBoard404ABV404ABV2021-12-16
10817522010311Kentec ArmBoard405AB405AB2021-12-16
10817522010328Kentec ArmBoard405ABV405ABV2021-12-16
10817522010281Kentec ArmBoard404AB404AB2021-12-16
10817522010694Ameritus TransducerATG200-TATG200-T2016-09-21
00817522013377SwabezeKMI-40KMI-402024-06-28
20817522013371SwabezeKMI-40KMI-402024-06-28
00817522013353SwabezeKMI-65KMI-652024-06-27
00817522013360SwabezeKMI-74KMI-742024-06-27
00817522013384SwabezeKMI-111KMI-1112024-06-27
20817522013357SwabezeKMI-65KMI-652024-06-27
20817522013364SwabezeKMI-74KMI-742024-06-27
20817522013388SwabezeKMI-111KMI-1112024-06-27
10817522013343SwabezeKMI-LAKMI-LA2024-06-20
20817522013340SwabezeKMI-LAKMI-LA2024-06-20
10817522010359AmeritusAMG-503-LGAMG-503-LG2016-08-01
10817522010366AmeritusAMG-503-SMAMG-503-SM2016-08-01
10817522013336Kentec electrodeAMG-503-PEDAMG-503-PED2024-04-25

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Primary DI, Brand, Company table
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10889483587959AirLife™AirLife Finland OyFMT2025-03-26
04048675436607Babyleo TN500Drägerwerk AG & Co. KGaAFMT2024-03-09
00865648000313NuBorne Infant WarmerINTERNATIONAL BIOMEDICAL, LTD.FMT2023-06-20
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10190752181199Airlife™AirLife Finland OyFMT2021-03-05
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