FDA.reportPublic FDA data

Philips Avent Single electric breast pump Advanced

Primary DI
00075020091499
Brand
Philips Avent Single electric breast pump Advanced
Company
Philips Consumer Lifestyle B.V.
Model
SCF392/61
Catalog number
SCF392/61
Device description
Powered breast pump consisting of a motor unit with a press-button user interface, and 1 expression kit (Cushion-type) with 1 milk collection container. With a rechargeable battery.
Published
2020-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K201381000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201381000Philips Avent Single/Double electric breast pump AdvancedPhilips Consumer Lifestyle - Innovation Site Eindhoven2020-10-01HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00075020091499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075020091499000750200914990750200914990075020091499

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, electricA mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31618191888aurore.millet@philips.com

Regulatory Flags#

DUNS number
489122720
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00075020120335Philips Lumea IPLBRC3442026-06-05
00075020120410Philips Lumea IPLBRC3322026-06-05
00075020107763Philips Lumea IPLBRI9842025-07-18
00075020108425Philips Lumea IPLBRI9372025-07-18
00075020108487Philips Lumea IPLBRI9322025-07-18
00075020108494Philips Lumea IPLBRI9312025-07-18
00075020109453Philips Avent Manual Breast PumpSCF430/03SCF430/032023-12-05
00075020107756Philips Avent Double Electric Breast PumpSCF393/82SCF393/822023-08-31
00075020070074Philips Avent Single Electric Breast PumpSCF332/21SCF332/212017-09-17
00075020070081Philips Avent Double Electric Breast PumpSCF334/22SCF334/222017-09-17
00075020070098Philips Avent Double Electric Breast Pump, Bottle & Brush setSCF334/23SCF334/232017-09-17
00075020070104Philips Avent Double Electric Breast PumpSCF334/25SCF334/252017-09-17
00075020070111Philips Avent Double Electric Breastfeeding setSCF334/26SCF334/262017-09-17
00075020060594Philips Avent Breast PumpSCF3342017-09-25
00075020063816Philips Avent Breast Pump SingleSCF3322016-09-17
00075020063823Philips Avent Breast Pump DoubleSCF3342016-09-17
00075020063830Philips Avent Breast PumpSCF3342016-09-17
00075020063847Philips Avent Breast PumpSCF3342016-09-17
00075020065803Philips Avent Breast PumpSCF3342016-09-17
00075020107770Philips Avent Double Breast Pump KitSCF338/52SCF338/522023-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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