FDA.reportPublic FDA data

Freemie

Primary DI
00851690007066
Brand
Freemie
Company
DAO HEALTH
Model
FG021
Device description
Medela Connection Spare Parts Kit
Published
2016-10-02
Public version status
Update
Distribution status
Not 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
10851690007063PackageGS112In Commercial Distribution
00851690007066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085169000706310851690007063
00851690007066008516900070668516900070660851690007066

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
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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
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
00020451904870Freestyle™ Mini Hands-freeMedela LLCHGX2026-05-01
08809108020017SpectraUZINMEDICARE CO.,LTDHGX2026-04-30
08809108020024SpectraUZINMEDICARE CO.,LTDHGX2026-04-30
19551028430006AmedaTPH TECHNOLOGY MALAYSIA SDN. BHD.HGX2026-03-03
07640108054975Ardo MeliaArdo medical AGHGX2026-02-27
08809108019912SpectraUZINMEDICARE CO.,LTDHGX2026-02-27
16973493597344TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493599430TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493592226MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493592431lansinoh Shenzhen TPH Technology Co., LtdHGX2026-02-25
16973493592530MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493593995MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493594244MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493594374MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493597078MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493597993MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493598235MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493598341MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493599362MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
00020451903873Motion InBra™Medela LLCHGX2026-02-16
00020451903880Motion InBra™Medela LLCHGX2026-02-16
08809108019684SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019691SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019707SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019714SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019769SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019776SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019783SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019790SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
08809108019820SpectraUZINMEDICARE CO.,LTDHGX2026-02-03