FDA.report

QUEST

Primary DI
00840216115248
Brand
QUEST
Company
Asp Global, LLC
Model
CVT001
Device description
6” X 9” 1.5MIL, EMPLOYER SOLUTIONS, W/3” FOLD OVER ADHESIVE CLOSURE, BIOHAZARD LOGO, 2.0MIL BACK POUCH, 4C/1S, 3” X 4” DESICCANT PAD, BAR CODED, 100/PK, 10/PKS, 1000/CS
Published
2022-08-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications

CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840216115248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216115248008402161152488402161152480840216115248

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080361159
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840216128262ASP GLOBALEGT3052025-11-20
00840216128286ASP GLOBALEGT3072025-11-20
00840216128804ASP GLOBAL PRIMOAFTS012025-06-30
00840216128279ASP GLOBALEGT3062025-06-17
00840216128293ASP GLOBALEGT3082025-06-17
00840216128842CARDINAL HEALTH AD6X10BILH2025-06-17
00840216128606LAPCORP LC4X6EZQ2025-05-13
00840216128613LAPCORP LC9X12MTL2025-05-13
00840216128163QUEST DIAGNOSTICSQD6.75X11AD2024-11-22
00840216127753ASP MEDICALMRT8002024-09-12
00840216128033ASP MEDICALMRACUP12024-09-12
20840216127566PRIMOAFTMATT2024-08-12
00840216120808PRIMOGGS3660TBH-K2024-03-05
00840216120853PRIMOGGS5670TBH-K2024-03-05
00840216121898PRIMOGGTS142024-03-05
00840216124509PRIMOGGTS13-K2024-03-05
00840216124516PRIMOGGTS14-5-K2024-03-05
00840216122697PRIMOAFPUMP2024-03-01
00840216125124PRIMOHB2002024-03-01
00840216125131PRIMOHB200B2024-03-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
10850044118721iHealthIHEALTH LAB INC.FLL2025-12-19
00328785012729VicksKAZ USA, INC.FLL2025-12-16
00328785012781BraunKAZ USA, INC.FLL2025-12-16
00328785014693BRAUNKAZ USA, INC.FLL2025-12-16