FDA.reportPublic FDA data

Nuby

Primary DI
30048526007197
Brand
Nuby
Company
LUV N' CARE, LTD.
Model
719
Published
2017-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical
PWNBaby Care Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2
PWNBaby Care KitGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023711000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023711000DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPEAcute Ideas Co. , Ltd.2002-11-21FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20048526007190PackageGS14In Commercial Distribution
30048526007197PackageGS112In Commercial Distribution
00048526007196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2004852600719020048526007190
3004852600719730048526007197
00048526007196000485260071960485260071960048526007196

GMDN Terms#

Term, Definition table
TermDefinition
Baby care kitA portable collection of devices and supplies designed to assist in the care of infants/babies. The collection typically includes a thermometer, medical measuring spoon/dropper, nasal aspirator, a teether, nail clippers, and grooming utensils (e.g., comb and brush). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
108926288
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
00039175811777Nuby811772025-01-07
00039175811784Nuby811772025-01-07
00039175811913Nuby811912024-11-21
00039175811920Nuby811912024-11-21
00048526007196Nuby7192017-03-23
00048526069385Nuby69382022-05-26
20048526069389Nuby69382022-05-26
00048526066483Nuby66482021-08-27
20048526066487Nuby66482021-08-27
00048526069378Nuby69372021-08-13
40048526069376Nuby69372021-08-13
00048526006212Nuby6212020-10-23
00048526068845Nuby68842020-10-23
00048526069095Nuby69092020-10-23
00048526069217Nuby69212020-10-23
20048526006216Nuby6212020-10-23
20048526068849Nuby68842020-10-23
20048526069099Nuby69092020-10-23
20048526069211Nuby69212020-10-23
00039175802744Nuby802742020-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyFLL2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyFLL2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
00749756389181DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
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00885403523475HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
06970289030859foreverlittleHetaida Technology Co., LtdFLL2026-07-28
06953825911638ZKZOShenzhen Urion Technology Co., LtdFLL2026-07-23
B353UB25511UbiqVue MultiparameterLifesignals, Inc.FLL2026-07-20
06972040114334N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
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06931973457109CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758502641CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758508865CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
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00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.FLL2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29