FDA.reportPublic FDA data

Freemie

Primary DI
00851690007707
Brand
Freemie
Company
DAO HEALTH
Model
FG089
Device description
19mm Fitmie SlimFit
Published
2021-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
HGXPump, Breast, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130349000FREEMIE BREAST COLLECTION SYSTEMDao Health2013-09-06HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851690007704PackageGS1100In Commercial Distribution
00851690007707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085169000770410851690007704
00851690007707008516900077078516900077070851690007707

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump support kit, reusableA collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.

Regulatory Flags#

DUNS number
022187754
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851690007646FreemieFG1192021-11-20
00851690007653FreemieFG1202021-11-20
00851690007660FreemieFG1212021-11-20
00851690007677FreemieFG1222021-11-20
00851690007684FreemieFG0862021-11-20
00851690007691FreemieFG0882021-11-20
00851690007714FreemieFG0912021-11-20
00851690007721FreemieFG0922021-11-20
00851690007738FreemieFG0932021-11-20
00851690007745FreemieFG0942021-11-20
00851690007752FreemieFG1052021-11-20
00851690007769FreemieFG1062021-11-20
00851690007776FreemieFG1072021-11-20
00851690007783FreemieFG0952021-11-20
00851690007790FreemieFG0962021-11-20
00851690007806FreemieFG0972021-11-20
00851690007813FreemieFG0982021-11-20
00851690007820FreemieFG0992021-11-20
00851690007837FreemieFG1002021-11-20
00851690007851FreemieFG1022021-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640108055903Breast shell sterile DeTach 12 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055927Breast shell sterile DeTach 13 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055941Breast shell sterile DeTach 14 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055965Breast shell sterile DeTach 15 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055989Breast shell sterile DeTach 16 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108056009Breast shell sterile DeTach 17 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055545Breast shell sterile DeTach 18 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055569Breast shell sterile DeTach 21 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055583Breast shell sterile DeTach 24 mm (2 pcs)Ardo medical AGHGX2026-07-30
06925546002285ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06925546003381ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06925546033821ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06937266900017FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900024FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900031FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900048FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900055FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900062FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900079FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900086FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900093FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900109FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900116FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900123FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900130FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
00020451906065Pump In Style Pro+ w/HarmonyMedela LLCHGX2026-07-20
00810104131018Willow Sync 5oz Container SetWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131025Willow Sync Container Back ReplacementWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131032Willow Sync Duckbill ValvesWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131049Willow Sync DiaphragmsWILLOW INNOVATIONS, INC.HGX2026-07-16