Wave, Handle, Replacement

GUDID 00810104131001

WILLOW INNOVATIONS, INC.

Breast pump, manual
Primary Device ID00810104131001
NIH Device Record Key87ab7091-8114-4243-87d8-3d0c1471d472
Commercial Distribution StatusIn Commercial Distribution
Brand NameWave, Handle, Replacement
Version Model NumberRHR116
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
GS100810104131001 [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
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
00810104131001 - Wave, Handle, Replacement2025-07-31

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