FDA.reportPublic FDA data

Green Sprouts

Primary DI
00715418091136
Brand
Green Sprouts
Company
O2cool, LLC
Model
222392-905-33
Catalog number
222392
Device description
Cooling Teether (2pk)-Pink Set Set-3mo+
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093370000FU HONG INDUSTRIES LIMITED SOOTHER TEETHERFu Hong Industries , Ltd.2010-01-21KKO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20715418091130PackageGS16In Commercial Distribution
30715418091137PackageGS12In Commercial Distribution
00715418091136PrimaryGS10
10715418091140Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2071541809113020715418091130
3071541809113730715418091137
00715418091136007154180911367154180911360715418091136
1071541809114010715418091140

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.

Regulatory Flags#

DUNS number
004603413
Device count
2
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00715418071640Green Sprouts379300-300-002021-06-01
00715418071657Green Sprouts379300-500-002021-06-01
00715418088563Green Sprouts379300-201-002021-06-01
00715418094045Green Sprouts379300-916-002021-06-01
00715418020358Green Sprouts222341-920-332223412016-08-23
00715418028590Green Sprouts222340-287-332017-04-12
00715418091143Green Sprouts222392-906-332223922016-09-15
00715418046464Green Sprouts309302-523-222021-06-01
00715418077291Green Sprouts242342-907-332021-06-01
00715418092843Green Sprouts22391-907-332021-06-01
00715418093314Green Sprouts222392-920-332021-06-01
00715418127620Green Sprouts264305-907-342021-06-01
00715418128023Green Sprouts221040-920-342021-06-01
00715418130095Green Sprouts221040-575-342021-06-01
00715418130101Green Sprouts221040-676-342021-06-01
00715418130118Green Sprouts221040-274-342021-06-01
00715418147208Green Sprouts385301-400-332021-06-01
00715418154688Green Sprouts385632-001-332021-06-01
00715418155333Green Sprouts758391-000-012021-06-01
00715418155340Green Sprouts758391-000-032021-06-01

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