FDA.reportPublic FDA data

Green Sprouts

Primary DI
30715418028591
Brand
Green Sprouts
Company
I PLAY. INC.
Model
222340-287-33
Published
2017-04-12
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

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
20715418028594PackageGS16In Commercial Distribution
30715418028591PackageGS12In Commercial Distribution
00715418028590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2071541802859420715418028594
3071541802859130715418028591
00715418028590007154180285907154180285900715418028590

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
131904450
Device count
1
DM exempt
true
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
30715418020359Green Sprouts222341-920-332223412016-08-23
30715418091137Green Sprouts222392-905-332223922016-09-15
30715418091144Green Sprouts222392-906-332223922016-09-15

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