FDA.reportPublic FDA data

96ct Milk Bag Package

Primary DI
00858298006477
Brand
96ct Milk Bag Package
Company
WILLOW INNOVATIONS, INC.
Model
B9651
Catalog number
B9651
Device description
96ct Milk Bag Package
Published
2020-12-15
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858298006477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858298006477008582980064778582980064770858298006477

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
050917861
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060442520004ElvieEL01 - Celeste2018-05-03
00810104131247Wave, Collection Cups, Tubing and Diaphragm Set, RetailCCDT382026-01-28
00810104131261Wave, Collection Cups, 3pc Adapter Set, ReplacementCCAS392026-01-28
00810104130929Wave, Collection Cups KitPMK202025-12-17
00810104130936 Wave Single Manual Pump KitPMK102025-07-23
00810104130943Willow Sync, Pump KitPEG252025-07-23
00810104130950Wave, Container 5oz, ReplacementRC05112025-07-23
00810104130967Wave, Gasket, 2 pack, RetailRG2P122025-07-23
00810104130974Wave, Flapper Valves, 4 pack, RetailRFL4132025-07-23
00810104130981Wave, Flange 24mm, ReplacementRF24142025-07-23
00810104130998Wave, Single, Tubing Set, RetailRSTS152025-07-23
00810104131001Wave, Handle, ReplacementRHR1162025-07-23
00810104130851Willow Go, 2 Splashguard Containers, 5ozL1GC052025-04-29
00810104130868Willow Go, 2 Splashguard Containers, 7ozL2GC072025-04-29
00810104130899Willow Go Splash Guard CCGSGR2025-04-29
00810104130790Silicone Wearable Breast PumpPP052025-04-28
00810104130875Willow Go, Replacement Container Bowl, 5ozR1GBR52025-04-28
00810104130882Willow Go, Replacement Container Bowl, 7ozR2GBR72025-04-28
05060442520561Elvie Pump Single AMZAEP01-01-N42025-02-11
05060442522077Elvie Stride 2EB01-212025-01-15

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