FDA.reportPublic FDA data

Philips Avent Double electric breast pump Advanced

Primary DI
00075020104045
Brand
Philips Avent Double electric breast pump Advanced
Company
Philips Consumer Lifestyle B.V.
Model
SCF393/52
Catalog number
SCF393/52
Device description
Powered breast pump consisting of a motor unit with a press-button user interface, INCLUDES; X2 PUMP BODY, X1 MOTOR UNIT, X2 4 FL. OZ. (125ML), BOTTLES, X1 ADAPTER, X2 BREAST PADS, X2 SEALING DISC. No rechargeable battery.
Published
2022-12-07
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
K203383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203383000Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62Philips Consumer Lifestyle - Innovation Site Eindhoven2020-12-15HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00075020104045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075020104045000750201040450750201040450075020104045

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

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
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
00007502005175Philips PulseReliefPR38412016-08-24
00075020104052Philips Avent Double electric breast pump AdvancedSCF394/52SCF394/522022-12-07

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