FDA.report

The Pump by Babyation

Primary DI
00850004964002
Brand
The Pump by Babyation
Company
Babyation Inc.
Model
BP1
Published
2022-05-25
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

Contact Domains

Product Codes

CodeName
HGXPump, Breast, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K173699000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K173699000The Pump by BabyationBabyation, LLC2018-04-04HGX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850004964019PackageGS11In Commercial Distribution
00850004964026PackageGS11In Commercial Distribution
00850004964040PackageGS11In Commercial Distribution
00850004964057PackageGS11In Commercial Distribution
00850004964002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004964019008500049640198500049640190850004964019
00850004964026008500049640268500049640260850004964026
00850004964040008500049640408500049640400850004964040
00850004964057008500049640578500049640570850004964057
00850004964002008500049640028500049640020850004964002

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.

Sterilization Methods

Method

Contacts

PhoneEmail
8447447867hi@babyation.com

Regulatory Flags

DUNS number
079845487
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

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28809108019688SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
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28809108019701SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
28809108019718SpectraUZINMEDICARE CO.,LTDHGX2026-02-03
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