FDA.reportPublic FDA data

Braun

Primary DI
00328785000535
Brand
Braun
Company
KAZ USA, INC.
Model
PC20KB
Device description
Braun ThermoScan PC20 Probe Covers, for use with PRO6000 series thermometers. This package contains 20 probe covers. Not for individual sale.The probe cover is intended for use as a sanitary barrier between the thermometer and ear canal.
Published
2016-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152748000Braun Thermoscan PRO 6000 Ear ThermometerKaz USA, Inc (A Subsidiary of Helen of Troy, Inc)2016-03-01FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00328785000535PrimaryGS10
10328785000365Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00328785000535003287850005353287850005350328785000535
1032878500036510328785000365

GMDN Terms#

Term, Definition table
TermDefinition
Electronic thermometer probe coverA device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-535-6663customerservice@welchallyn.com

Regulatory Flags#

DUNS number
122612547
Device count
20
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00328785014303BRAUNBUA4000BUS2025-09-19
00328785000160SoftheatHP910V12019-09-04
00092926503208HoneywellHEV320B2018-03-30
00328785001334HONEYWELLHWM845B2018-08-01
00328785001723HONEYWELLHUL430W2018-08-01
00328785002362HONEYWELLHWC775B2021-09-30
00328785004083HoneywellHWM440W2020-08-17
00328785004113HoneywellHWM440B2020-08-17
00328785006247HoneywellHWC775W2021-09-30
00328785006537HoneywellHUL525B2021-10-15
00328785006544HoneywellHUL525W2021-10-15
00328785006575HoneywellHUL545B2021-10-15
00328785006612HoneywellHUL545W2021-10-15
00328785006629HoneywellHUL5302021-10-15
00328785006636HoneywellHUL565B2021-10-15
00328785004106HoneywellHWM445B2020-08-17
00328785000054BraunIRT6500US2016-09-09
00328785000092Braun IRT6020USIRT6020US2016-09-09
00328785000276VicksV912USV12016-11-04
00328785000450Kaz821-242016-09-09

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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22