FDA.reportPublic FDA data

NaturalWave Fast Flow Teats-2pcs L size

Primary DI
30044677710252
Brand
NaturalWave Fast Flow Teats-2pcs L size
Company
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
Model
P71025-00
Device description
It is used with milk bottle to provide milk flow during 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
40044677710259PackageGS14In Commercial Distribution
30044677710252PrimaryGS10
00044677710251Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4004467771025940044677710259
3004467771025230044677710252
00044677710251000446777102510446777102510044677710251

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
502960539
Device count
2
DM exempt
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
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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