FDA.report

Viva Diagnostic

Primary DI
00840309415880
Brand
Viva Diagnostic
Company
Tiger Supplies Inc
Model
ADIME913-T
Device description
"Infrared Thermometer"
Published
2024-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840309415880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840309415880008403094158808403094158800840309415880

GMDN Terms

TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
013719334
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
true
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 DIBrandModelCatalogPublished
00840309415903Viva DiagnosticADIME913-M2024-06-01
00840309416054Viva DiagnosticADIME913-S2024-06-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06970289030118hetaidaHetaida Technology Co., LtdFLL2026-05-24
06970289035120hetaidaHetaida Technology Co., LtdFLL2026-05-24
06970289035137hetaidaHetaida Technology Co., LtdFLL2026-05-23
06970289035144hetaidaHetaida Technology Co., LtdFLL2026-05-23
06953205995043Infrared ThermometerShenzhen Jiacom Technology Co., LtdFLL2026-03-20
00850022483370Dr. Noze Best ThermometerDr. Noze Best, LLCFLL2026-03-17
00851203006449TempTraq®BLUE SPARK TECHNOLOGIES, INC.FLL2026-02-26
00851203006470TempTraq®BLUE SPARK TECHNOLOGIES, INC.FLL2026-02-26
00851203006487TempTraq®BLUE SPARK TECHNOLOGIES, INC.FLL2026-02-26
00628693098144ByFloProductsByFlo LLCFLL2026-02-18
16972040113723TizziorShenzhen AOJ Medical Technology Co., LtdFLL2026-02-05
16972040113730TizziorShenzhen AOJ Medical Technology Co., LtdFLL2026-02-05
20328785004674VicksKAZ USA, INC.FLL2026-02-04
00328785004908BraunKAZ USA, INC.FLL2026-02-04
00328785005301VicksKAZ USA, INC.FLL2026-02-04
00328785006285VicksKAZ USA, INC.FLL2026-02-04
40328785013984BRAUNKAZ USA, INC.FLL2026-02-04
10328785007975BraunKAZ USA, INC.FLL2026-02-03
00328785008272BraunKAZ USA, INC.FLL2026-02-03
00328785012989BRAUNKAZ USA, INC.FLL2026-02-03
10328785014744BRAUNKAZ USA, INC.FLL2026-02-03
10328785006350VicksKAZ USA, INC.FLL2026-01-28
00328785012798BRAUNKAZ USA, INC.FLL2026-01-28
00328785014655BRAUNKAZ USA, INC.FLL2026-01-28
00328785014662BRAUNKAZ USA, INC.FLL2026-01-27
00328785014716BRAUNKAZ USA, INC.FLL2026-01-27
10311917052264WalgreensWALGREEN CO.FLL2025-12-31
06971567043066E+RWenzhou Yosun Medical Technology Co., Ltd.FLL2025-12-29
10850044118691iHealthIHEALTH LAB INC.FLL2025-12-19
10850044118707iHealthIHEALTH LAB INC.FLL2025-12-19