FDA.reportPublic FDA data

Gentle Feed

Primary DI
10822383550296
Brand
Gentle Feed
Company
Drive Devilbiss Healthcare
Model
MQ9130
Device description
BREAST PUMP
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
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
K132882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132882000ELECTRIC BREAST PUMPShantou Xinghe Electrical Apparatuses Co., Ltd.2014-04-24HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10822383550296PackageGS14In Commercial Distribution
00822383550299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082238355029610822383550296
00822383550299008223835502998223835502990822383550299

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
867673159
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00822383027180DECO, 5L Oxygen Concentrator5DECO2DS2026-10-29
00822383035482SIMO2, Portable Oxygen ConcentratorSIMO2DS2026-10-29
00822383036885SIMO2, Portable Oxygen Concentrator, Extended BatterySIMO2DS-EB2026-10-29
00023601061102Carex Health BrandsFGR11000 00002016-10-07
00092237614419Roscoe MedicalHUM-ROS62018-12-19
50050428250391DRIVEMEDICAL7417372019-06-21
00311917192352Walgreens9847282019-06-21
00822383989815DRIVEMEDICAL146-RTLPC23201-M2019-06-21
00822383989839DRIVEMEDICAL146-RTLPC23201-F2019-06-21
00822383246420DriveRTLPC23201-F2017-05-19
00822383037127Silver SportBIN-SSP316DDA-SF2026-06-22
00822383037134Silver SportBIN-SSP218DDA-SF2026-06-22
00822383037141Silver SportBIN-SSP220DDA-SF2026-06-22
00822383037158Cruiser 3 16"BIN-K316ADDA-SF2026-06-22
00822383037165Cruiser 3 18"BIN-K318ADDA-SF2026-06-22
00822383037172Cruiser 3 20"BIN-K320ADDA-SF2026-06-22
00194346283439EquateEQKW5002026-06-10
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978342980202MisskidGuangdong Youmeng Electrical Technology Co., Ltd.HGX2026-11-02
06978342980219MisskidGuangdong Youmeng Electrical Technology Co., Ltd.HGX2026-11-02
06940657923557WillowGuangdong Horigen Mother & Baby Products Co., Ltd.HGX2026-10-28
08809108020307SpectraUZINMEDICARE CO.,LTDHGX2026-10-28
08809108020338SpectraUZINMEDICARE CO.,LTDHGX2026-10-28
08809108020345SpectraUZINMEDICARE CO.,LTDHGX2026-10-28
06975740364177MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-10-23
16975740363917MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-10-23
06975740363477MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
06975740363484MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
06975740363750MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
06975740363767MomcozyShenzhen Root Innovation Technology Co., Ltd.HGX2026-09-20
00850000125506Primo PassiPrimo Passi LLCHGX2026-09-19
09420060218022haakaaTHINK GREEN LIMITEDHGX2026-09-18
09420060218053haakaaTHINK GREEN LIMITEDHGX2026-09-18
04897152760014eufy Wearable Breast PumpAnker Innovations LimitedHGX2026-08-21
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