FDA.reportPublic FDA data

Nuby

Primary DI
00048526007196
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 not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
PWNBaby Care Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
Infant care kitA portable collection of devices and supplies designed to assist in the care of an infant/baby that typically includes two or more of the following: a thermometer, medical measuring spoon/dropper, nasal aspirator, irrigation saline solution, a teether, and nail clippers. This is a reusable device.

Regulatory Flags#

DUNS number
108926288
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00039175811777Nuby811772025-01-07
00039175811784Nuby811772025-01-07
00039175811913Nuby811912024-11-21
00039175811920Nuby811912024-11-21
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
00039175802751Nuby802752020-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00350770003498NEOMED*Avanos Medical, Inc.PWN2022-04-28
00350770003504NEOMED*Avanos Medical, Inc.PWN2022-04-28
00350770003511NEOMED*Avanos Medical, Inc.PWN2022-04-28
00350770003528NEOMED*Avanos Medical, Inc.PWN2022-04-28
00350770003535NEOMED*Avanos Medical, Inc.PWN2022-04-28
00350770003542NEOMED*Avanos Medical, Inc.PWN2022-04-28
00350770003559NEOMED*Avanos Medical, Inc.PWN2022-04-28
00350770003566NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003495NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003501NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003518NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003525NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003532NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003549NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003556NEOMED*Avanos Medical, Inc.PWN2022-04-28
10350770003563NEOMED*Avanos Medical, Inc.PWN2022-04-28
30048526007197NubyLUV N' CARE, LTD.PWN2017-03-23