FDA.report

Powered breast pump

Primary DI
08800051100504
Brand
Powered breast pump
Company
IMANI
Model
imani i2Plus
Device description
2pumps with iBox
Published
2023-03-27
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

Related Records

Product Codes

CodeName
HGXPump, Breast, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K222573000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K222573000imani i2Plus Breast PumpImani Co.2023-03-03HGX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800051100504PrimaryGS10

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
695625852
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800051100627Powered breast pumpimani i2Plus Pro2025-12-03
08800051100634Powered breast pumpimani i2Plus Pro2025-12-03
08800051100641Powered breast pumpimani i2Plus Pro2025-12-03
08800051100542Powered breast pumpimani i2Plus2023-05-02
08800051100559Powered breast pumpimani i2Plus2023-05-02
08800051100566Powered breast pumpimani i2Plus2023-05-02
08800051100290Powered breast pumpimani i2Plus2023-03-27
08800051100474Powered breast pumpimani i2Plus2023-03-27
08800051100498Powered breast pumpimani i22022-09-27
08800051100115Powered breast pumpimani i1Plus2022-05-06
08800051100047Powered breast pumpimani i12021-06-01
08800051100108Powered breast pumpimani i22021-06-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04897152760045eufy Wearable Breast Pump S1 ProAnker Innovations LimitedHGX2026-03-14
04897152760052eufy Wearable Breast Pump E10Anker Innovations LimitedHGX2026-03-14
04897152760069eufy Wearable Breast Pump E20Anker Innovations LimitedHGX2026-03-14
04897152760038eufy Wearable Breast Pump S1Anker Innovations LimitedHGX2026-03-13
39551028430000AmedaTPH TECHNOLOGY MALAYSIA SDN. BHD.HGX2026-03-03
07640108054982Ardo MeliaArdo medical AGHGX2026-02-27
28809108019916SpectraUZINMEDICARE CO.,LTDHGX2026-02-27
26973493597341TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
26973493599437TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493598419AmedaShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493592223MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493592438lansinoh Shenzhen TPH Technology Co., LtdHGX2026-02-25
26973493592537MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493593992MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493594241MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493594371MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493597075MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493597990MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493598232MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493598348MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
26973493599369MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
00020451904566Motion InBra™Medela LLCHGX2026-02-16
00020451904573Motion InBra™Medela LLCHGX2026-02-16
00850083182007MamaproInterfocus Inc.HGX2026-02-13
00810178887170ViveVIVE HEALTH LLCHGX2026-02-09
28809108019688SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019695SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019701SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019718SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019763SpectraUZINMEDICARE CO.,LTDHGX2026-02-03