FDA.reportPublic FDA data

Lansinoh

Primary DI
00044677533515
Brand
Lansinoh
Company
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
Model
Smartpump 3.0 Double Electric Breast Pump
Catalog number
53351
Device description
The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby.
Published
2023-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HGXPump, Breast, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222726000Smartpump 3.0 Double Electric Breast PumpLansinoh Laboratories2022-12-23HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60044677533517PackageGS16In Commercial Distribution
00044677533515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6004467753351760044677533517
00044677533515000446775335150446775335150044677533515

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature41 Degrees Fahrenheit95 Degrees Fahrenheit

Regulatory Flags#

DUNS number
502960539
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00044677537506LansinohCompact Wearable Pump537502023-07-17
60044677533517Lansinoh Smartpump 3.0 Double Electric Breast Pump533512023-07-03
00044677532501Lansinoh Smart Pump 2.0DEBP 4.0532162019-12-02
60044677532169Lansinoh Smart Pump 2.0DEBP 4.0532162019-12-02
10044677532508Lansinoh Smart 2.0 PumpDEBP 4.0532502019-12-02
30044677710269NaturalWave Medium Flow Teats-2pcs M sizeP71026-002018-09-27
00044677710534Lansinoh 5oz Bottle with Natural WaveNippleP71053-002018-09-27
00044677710558Lansinoh 8oz Bottle with NaturalWave NippleP71055-002018-09-27
20044677710545Lansinoh 5oz Bottle with NaturalWave Nipple– Triple PackP71054-002018-09-27
20044677710569Lansinoh 8oz Bottle with NaturalWave Nipple – Triple PackP71056-002018-09-27
30044677204157Lansinoh Breastmilk Storage Bottle-4 PackP20415-012018-09-27
30044677710252NaturalWave Fast Flow Teats-2pcs L sizeP71025-002018-09-27
40044677710266NaturalWave Medium Flow Teats-2pcs M sizeP71026-002018-09-27
30044677710276NaturalWave Slow Flow Teats - 2pcs S sizeP71027-002018-09-27
00044677531498Lansinoh Smart Pump Base OnlyDEBP 2.2P53149-012018-03-01
20044677505202Lansinoh Manual Breast PumpMBP 1.0505202017-12-05
00044677530163Lansinoh Signature Pro - DMEDEBP 2.1530162017-12-05
00044677530491Lansinoh Signature Pro Enclosure UnitDEBP 2.1530492017-12-05
00044677530507Lansinoh Signature Pro DEBPDEBP 2.1530502017-12-05
00044677531160Lansinoh Smart Pump - DMEDEBP 2.2531162017-12-05

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