FDA.reportPublic FDA data

Freemie

Primary DI
10851690007155
Brand
Freemie
Company
DAO HEALTH
Model
FG032
Device description
Freemie Equality Deluxe Set
Published
2016-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
10851690007155PackageGS112In Commercial Distribution
00851690007158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085169000715510851690007155
00851690007158008516900071588516900071580851690007158

GMDN Terms#

Term, Definition table
TermDefinition
Suction system bottleA cylindrical sealable container made of glass or plastic (typically chemical resistant) that is used as a component of a suction system, or other system that utilizes suction, for the collection of aspirated waste materials (e.g., blood, bodily fluids, laser plume evacuation gas) and/or body tissue intended for diagnostic/therapeutic purposes (e.g., histological analysis, autologous fat tissue transfer) from a site of operation. It may be used singularly or in a connected series to provide greater capacity, and may be calibrated to facilitate determination of the quantity of its contents. Suction system bottles are not used in conjunction with suction liners. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
022187754
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

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
00851690007707FreemieFG0892021-11-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810104131056Willow Sync 24mm FlangesWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131063Willow Sync Tubing AssemblyWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131087Willow Sync Receiver ReplacementWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131094Willow Sync Replacement PumpWILLOW INNOVATIONS, INC.HGX2026-07-16
00879388005132Rumble TuffA Cute Baby IncHGX2026-07-05
06935883910013Figaroo™ GoFlowHuizhou LVB Maternal & Infant Supplies Co., Ltd.HGX2026-07-03
06951727603019Figaroo™ EnduraShenzhen Changkun Technology Co., Ltd.HGX2026-06-26
06951727603033Figaroo™ DashShenzhen Changkun Technology Co., Ltd.HGX2026-06-26
26973493590991Figaroo™ElevateShenzhen TPH Technology Co., LtdHGX2026-06-22
26973493592834Figaroo™ EaseShenzhen TPH Technology Co., LtdHGX2026-06-22
08809444071049HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071056HaenimHaenim Co.,Ltd.HGX2026-06-05