FDA.reportPublic FDA data

Lamaze

Primary DI
B268L276198
Brand
Lamaze
Company
TOMY INTERNATIONAL, INC.
Model
L27619
Catalog number
L27619
Device description
Water Filled Chill Teethers
Published
2018-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KKORing, Teething, Fluid-Filled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKORing, Teething, Fluid-FilledDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B268L276192PackageHIBCC2In Commercial Distribution
B268L276198PackageHIBCC4In Commercial Distribution
B268L276199PackageHIBCC3In Commercial Distribution
B268L276190PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Teething device, fluid-filledA circular or cylindrical device filled with fluid (e.g., water) intended to be bitten by a patient (infant or adult) to soothe gums during the teething process. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065183758
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B268L274120LAMAZE/JOHN DEEREL27412L274122019-09-23
B268Y7078A80The First YearsY7078A8Y7078A82025-09-22
B268Y7078A81The First YearsY7078A8Y7078A82025-09-22
B26879570The First YearsY7957Y79572024-01-18
B268L276190LamazeL27619L276192018-07-01
B268Y108960American Red CrossY10896Y108962017-11-13
B268Y5288L0LamazeY5228L2019-10-11
B268Y60530The First YearsY60532017-02-11
B268Y62280The First YearsY62282017-02-11
B268Y7054Y70570American Red CrossY7054, Y7057Y70572017-12-29
B268Y7054Y705701American Red CrossY7054Y70542017-12-20
B268Y70780American Red CrossY70782016-09-23
B268Y71490American Red CrossY71492017-05-29
B268Y77900American Red CrossY7790Y77902017-11-15
B268Y79160American Red CrossY7916Y79162022-03-31
B268Y78251American Red CrossY7825Y7825A12019-11-04
B268Y52880The First YearsY52882017-02-11
B268Y7078A70The First YearsY7078A7Y7078A72024-03-25
B268Y7078A71The First YearsY7078A7Y7078A72024-03-25
B268Y79571The First YearsY7957Y79572024-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00037977810318SassySASSY BABY, INC.KKO2026-05-21
00810028770508FridaFridababy, LLCKKO2025-07-02
10810028770505FridaFridababy, LLCKKO2025-07-02
B740TE0310Dr. Brown'sDr. Brown's CompanyKKO2025-05-23
00039175811777NubyLUV N' CARE, LTD.KKO2025-01-07
00039175811784NubyLUV N' CARE, LTD.KKO2025-01-07
00850036799573Castle Teething Ring Supermouth LLCKKO2024-06-01
06975983272352MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.KKO2024-04-23
06975983272369MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.KKO2024-04-23
B740TE0280Dr. Brown'sDr. Brown's CompanyKKO2023-09-20
B740TE0290Dr. Brown'sDr. Brown's CompanyKKO2023-09-20
00037977808193SassySASSY BABY, INC.KKO2023-08-29
00037977808247SassySASSY BABY, INC.KKO2023-08-29
00074451131583Baby EinsteinKIDS II, INC.KKO2023-08-21
00074451167735Baby EinsteinKIDS II, INC.KKO2023-04-28
00074451168817IngenuityKIDS II, INC.KKO2023-04-28
00074451168824IngenuityKIDS II, INC.KKO2023-04-28
00048526069385NubyLUV N' CARE, LTD.KKO2022-05-26
20048526069389NubyLUV N' CARE, LTD.KKO2022-05-26
B740TE0240Dr. Brown'sDr. Brown's CompanyKKO2022-01-31
00048526066483NubyLUV N' CARE, LTD.KKO2021-08-27
20048526066487NubyLUV N' CARE, LTD.KKO2021-08-27
00048526069378NubyLUV N' CARE, LTD.KKO2021-08-13
40048526069376NubyLUV N' CARE, LTD.KKO2021-08-13
00715418093314Green SproutsO2cool, LLCKKO2021-06-01
00715418127620Green SproutsO2cool, LLCKKO2021-06-01
00715418020341Green SproutsO2cool, LLCKKO2021-05-31
00715418028606Green SproutsO2cool, LLCKKO2021-05-31
00037977809275Sassy SASSY BABY, INC.KKO2021-02-25
00074451124868Baby EinsteinKIDS II, INC.KKO2021-01-13