FDA.reportPublic FDA data

Shopko

Primary DI
10400119854391
Brand
Shopko
Company
VERIDIAN HEALTHCARE LLC
Model
72-332
Catalog number
72-332
Device description
ShopkoTemple Touch Premium Thermomete
Published
2016-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
false
Sterile
false
Single use
false

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
K051422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051422000DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICEMedisim, Ltd.2005-09-01FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10400119854391PackageGS136In Commercial Distribution
30400119854395PackageGS13In Commercial Distribution
00400119854394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1040011985439110400119854391
3040011985439530400119854395
00400119854394004001198543944001198543940400119854394

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, battery-powered, electronic instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-4 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-326-1313info@veridianhealthcare.com

Regulatory Flags#

DUNS number
830437997
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845717013574SMARTHEART11-51D2026-09-29
00845717013765SMARTHEART11-51DA2026-09-29
00845717012188Trackstar302-111152026-09-04
00845717013055Trackstar302-1114BSL2026-09-04
00845717013062Trackstar302-1113BB2026-09-04
00845717012171Trackstar302-WS3802026-05-28
00845717015509SmartHeart01-5502026-05-27
00845717012096Trackstar302-2110B2025-09-15
00845717013192SmartHeart UAM-710SH2025-12-12
10845717013199SmartHeart UAM-710SH2025-12-12
00682891216021Zewa216022024-06-21
00682891216014Zewa216012020-04-14
00845717010139Veridian Healthcare11-50Q12025-09-09
30845717010130Veridian Healthcare11-50Q12025-09-09
00845717011785R.P.M. PRO210-1114B2025-09-08
00845717011945R.P.M. PRO210-3110B2025-09-08
00845717012164Trackstar302-1110B2025-09-08
00845717011020Veridian Healthcare01-5742024-09-10
00845717011068R.P.M. PRO210-1113B2025-09-02
00845717011938R.P.M. PRO210-1113C2025-09-02

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