FDA.reportPublic FDA data

PC600 Digital Thermometer - White

Primary DI
00030028000041
Brand
PC600 Digital Thermometer - White
Company
Broder Bros., Co.
Model
PC600
Catalog number
PC600
Device description
PC600 Digital Thermometer - White• ABS Plastic thermometer with 1 button cell battery (AG3), replaceable. • Each thermometer comes in 2-piece plastic storage case. Imprint on case only.• Power/Technology: Range 90.0 108.0 F. Accuracy - 0.3 F Less than 95.0 F, 0.2 F 95.0 F to 102.0 F, 0.3 F Greater than 102.0 F. Measures 77.0 F at standard room temperature.• Refer to instructions (included) for cleaning.• Features On/Off switch and 3 1/2 digit LCD display.• For oral and under-arm use only. • Takes approx. 10 seconds to read temperature, at which time device emits beeping sound. Temperature shows on display 30-60 seconds after sound goes off.
Published
2017-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10030028000048PackageGS110In Commercial Distribution
20030028000045PackageGS1300In Commercial Distribution
00030028000041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003002800004810030028000048
2003002800004520030028000045
00030028000041000300280000410300280000410030028000041

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent electronic patient thermometerA hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-877-858-9908customerservice@jetlinepromo.com

Regulatory Flags#

DUNS number
005381652
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00030028000089Source Abroad PL-2335PL-23352018-04-20
00030028000003Digital Thermometer PL-1815PL-18152016-09-14
00030028000010Digital ThermometerPL-1815PL-18152016-09-14
00030028000027Source Abroad PL-2335PL-23352016-10-12
00030028000034Source AbroadSA-700175 2016-10-21
00030028000058Digital ThermometerPL-1815PL-18152017-01-23
00030028000065Source AbroadPL-2335PL-23352017-06-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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