FDA.reportPublic FDA data

Lansinoh 8oz Bottle with NaturalWave Nipple

Primary DI
00044677710558
Brand
Lansinoh 8oz Bottle with NaturalWave Nipple
Company
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
Model
P71055-00
Device description
It is used for baby feeding.
Published
2018-09-27
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10044677710555PackageGS112In Commercial Distribution
40044677710556PackageGS14In Commercial Distribution
00044677710558PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004467771055510044677710555
4004467771055640044677710556
00044677710558000446777105580446777105580044677710558

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 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
1

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
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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