FDA.reportPublic FDA data

Pump In Style Advanced

Primary DI
10020451364480
Brand
Pump In Style Advanced
Company
MEDELA, INC.
Model
Pump In Style Advance Backpack
Catalog number
101036453;101036448
Device description
Powered Breast Pump
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
K181937000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181937000Pump In Style Advanced, Advanced Personal Double BreastpumpMedela, LLC2018-10-16HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10020451364480PackageGS13In Commercial Distribution
10020451364534PackageGS11In Commercial Distribution
00020451364537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002045136448010020451364480
1002045136453410020451364534
00020451364537000204513645370204513645370020451364537

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
1-800-435-8316customer.service@medela.com

Regulatory Flags#

DUNS number
052002029
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
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
2002045146457618mm PersonalFit™ Plus Breast shields1010464572024-05-21
10020451416240Solo™1010416242024-05-15
10020451467099Swing Maxi™ Hands-free1010467092024-05-14
20020451463623Pediatric Breast Pump Kit with Harmony1010463622024-05-08
20020451464477Breast Pump Kit with Harmony & 80mL container1010464472024-05-08
20020451101303ENFit Syringe 1mlENF01LD1010331592024-05-06
20020451100603Enteral FeedingENPU-16-402016-09-22
20020451331083Enteral FeedingENPU16402017-12-20
10020451101719Enteral FeedingENFDUALCAPCNSLD2017-01-27
20020451100894Enteral FeedingINT-CAP2016-09-22
20020451101181Enteral FeedingTL-CAP2016-09-22
10020451101467Enteral FeedingENFMEDCAPNSLD2016-09-22
20020451101709Enteral FeedingENFDUALCAPCLD2017-01-27
00020451463445Colostrum Protector1010463442023-11-01
20020451457837Hands-free Breast shields, 27mm1010457832023-10-30
20020451101402Enteral FeedingENFCAPLD2016-09-22
20020451101419Enteral FeedingENFDUALCAPLD2016-09-22
10020451101429Enteral FeedingENFDUALCAPNSLD2016-09-22
20020451101433Enteral FeedingENFFEMALELD2016-09-22
20020451101440Enteral FeedingENFMALELD2016-09-22

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Primary DI, Brand, Company table
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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
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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
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