FDA.reportPublic FDA data

NaturalWave Medium Flow Teats-2pcs M size

Primary DI
40044677710266
Brand
NaturalWave Medium Flow Teats-2pcs M size
Company
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
Model
P71026-00
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
Rx
false
OTC
false
Sterile
false
Single use
false

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
40044677710266PackageGS14In Commercial Distribution
30044677710269PrimaryGS10
00044677710268Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4004467771026640044677710266
3004467771026930044677710269
00044677710268000446777102680446777102680044677710268

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
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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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