FDA.reportPublic FDA data

Best Choice

Primary DI
00070038605157
Brand
Best Choice
Company
VALU MERCHANDISERS COMPANY
Model
753
Device description
25 pack of probe covers. A device intended to be used as a physical barrier between the patient and the probe of a thermometer to prevent cross-contamination between patients. This is a single-use device.
Published
2016-09-20
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20070038605151PackageGS16In Commercial Distribution
40070038605155PackageGS124In Commercial Distribution
00070038605157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2007003860515120070038605151
4007003860515540070038605155
00070038605157000700386051570700386051570070038605157

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.

Contacts#

Phone, Email table
PhoneEmail
303-271-0300info@180innovations.com

Regulatory Flags#

DUNS number
868703513
Device count
1
Lot or batch
true

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00070038596028Best Choice TamponsBAWAC402016-09-20
00070038610618Best Choice TamponsBAWGR202016-09-20
00070038610632Best Choice TamponsBAWGS182016-09-20
00070038622666Best Choice TamponsBAWGC362016-09-20
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