FDA.reportPublic FDA data

Lansinoh Manual Breast Pump

Primary DI
20044677505202
Brand
Lansinoh Manual Breast Pump
Company
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
Model
MBP 1.0
Catalog number
50520
Device description
The Non-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
2017-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HGYPump, Breast, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGYPump, Breast, Non-PoweredObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60044677505200PackageGS16In Commercial Distribution
20044677505202PrimaryGS10
00044677505208Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6004467750520060044677505200
2004467750520220044677505202
00044677505208000446775052080446775052080044677505208

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, manualA hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Regulatory Flags#

DUNS number
502960539
Device count
2
Premarket exempt
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00044677537506LansinohCompact Wearable Pump537502023-07-17
00044677533515Lansinoh Smartpump 3.0 Double Electric Breast Pump533512023-07-03
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
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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