FDA.reportPublic FDA data

Fun Ice Chewy Teether- 2pk

Primary DI
10735282740029
Brand
Fun Ice Chewy Teether- 2pk
Company
MUNCHKIN, INC.
Model
74002
Device description
Cool gel that soothes gums Ridges to massage sore gums Easy-to-grasp hand/ foot shape
Published
2019-02-13
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
false

Contact Domains#

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
10735282740029PackageGS124In Commercial Distribution
00735282720024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1073528274002910735282740029
00735282720024007352827200247352827200240735282720024

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

Contacts#

Phone, Email table
PhoneEmail
1-800-344-2229cserve@munchkin.com

Regulatory Flags#

DUNS number
787026855
Device count
1
DM exempt
true
Premarket exempt
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10735282287845MunchkinMKCA0999 Rev 12026-03-18
00735282213182TheraBurpee Reusable Hot & Cold Gel Packs - 2pk213182021-10-01
00735282286810MunchkinMKFE0964 Rev 1286812025-02-12
10735282286817MunchkinMKFE0964 Rev 1286812025-02-12
00735282281310MunchkinMKFE0951 Rev 2281312024-11-14
00735282281327MunchkinMKFE0952 Rev 2281322024-11-14
00735282281334MunchkinMKFE0951 Rev 1281332024-11-14
00735282281358MunchkinMKFE0952 Rev 1281352024-11-14
10735282281317MunchkinMKFE0951 Rev 2281312024-11-14
10735282281324MunchkinMKFE0952 Rev 2281322024-11-14
10735282281331MunchkinMKFE0951 Rev 1281332024-11-14
10735282281355MunchkinMKFE0952 Rev 1281352024-11-14
00735282381843MunchkinMKFE0927 Rev 1381842024-08-01
00735282381850MunchkinMKFE0923 Rev 1381852024-08-01
00735282383946MunchkinMKFE0927 Rev 1383942024-08-01
10735282381840MunchkinMKFE0927 Rev 1381842024-08-01
10735282381857MunchkinMKFE0923 Rev 1381852024-08-01
10735282383943MunchkinMKFE0927 Rev 1383942024-08-01
00735282383236MunchkinMKFE0924 Rev 1383232024-06-25
00735282383243MunchkinMKFE0924 Rev 2383242024-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B740TE2150Dr. Brown'sDr. Brown's CompanyKKO2026-06-08
B740TE2300Dr. Brown'sDr. Brown's CompanyKKO2026-06-08
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