Wave Single Manual Pump Kit

GUDID 00810104130936

WILLOW INNOVATIONS, INC.

Breast pump, manual
Primary Device ID00810104130936
NIH Device Record Keybf03a8e4-8f92-42a6-a1c9-92b62dc43c45
Commercial Distribution StatusIn Commercial Distribution
Brand NameWave Single Manual Pump Kit
Version Model NumberPMK10
Company DUNS050917861
Company NameWILLOW INNOVATIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810104130936 [Primary]

FDA Product Code

HGYPump, Breast, Non-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-31
Device Publish Date2025-07-23

Devices Manufactured by WILLOW INNOVATIONS, INC.

00810104130936 - Wave Single Manual Pump Kit2025-07-31
00810104130936 - Wave Single Manual Pump Kit2025-07-31
00810104130943 - Willow Sync, Pump Kit2025-07-31
00810104130950 - Wave, Container 5oz, Replacement2025-07-31
00810104130967 - Wave, Gasket, 2 pack, Retail2025-07-31
00810104130974 - Wave, Flapper Valves, 4 pack, Retail2025-07-31
00810104130981 - Wave, Flange 24mm, Replacement2025-07-31
00810104130998 - Wave, Single, Tubing Set, Retail2025-07-31
00810104131001 - Wave, Handle, Replacement2025-07-31

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