FDA.reportPublic FDA data

Ameda, Inc.

Primary DI
00810725021477
Brand
Ameda, Inc.
Company
AMEDA, INC.
Model
17077MN
Catalog number
17077MN
Device description
Purely Yours Pump w/ Carry All
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
K973501000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973501000EXPRESSE AND PREMIER POWERED BREAST PUMPSAmeda Medizintechnik AG1997-12-11HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810725021477Direct MarkingGS10
10810725020408PackageGS11In Commercial Distribution
10810725020798PackageGS11In Commercial Distribution
10810725021641PackageGS12In Commercial Distribution
20810725020375PackageGS14In Commercial Distribution
00810725020371PrimaryGS10
00810725020401PrimaryGS10
00810725020425PrimaryGS10
00810725020432PrimaryGS10
00810725020791PrimaryGS10
00810725020807PrimaryGS10
00810725020906PrimaryGS10
00810725021644PrimaryGS10
00810725021675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810725021477008107250214778107250214770810725021477
1081072502040810810725020408
1081072502079810810725020798
1081072502164110810725021641
2081072502037520810725020375
00810725020371008107250203718107250203710810725020371
00810725020401008107250204018107250204010810725020401
00810725020425008107250204258107250204250810725020425
00810725020432008107250204328107250204320810725020432
00810725020791008107250207918107250207910810725020791
00810725020807008107250208078107250208070810725020807
00810725020906008107250209068107250209060810725020906
00810725021644008107250216448107250216440810725021644
00810725021675008107250216758107250216750810725021675

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
Storage Environment Temperature-20 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(866) 992-6332parentcare@ameda.com

Regulatory Flags#

DUNS number
078719435
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00810725026168Ameda, Inc.201X09201X092025-09-09
00810725026175Ameda, Inc.201X10201X102025-09-09
00810725026182Ameda, Inc.201X11201X112025-09-09
00810725026199Ameda, Inc.201X12201X122025-09-09
00810725026205Ameda, Inc.201X13201X132025-09-09
00810725026212Ameda, Inc.201W01H201W01H2025-09-09
00810725026250Ameda, Inc.201W23201W232025-09-09
00810725025574AmedaMya Joy PLUS132A042021-07-16
00810725025581AmedaMya Joy PLUS132A052021-07-16
00810725025598AmedaMya Joy PLUS132A062021-07-16
00810725025772AmedaMya Joy PLUS132W122021-07-16
00810725025864AmedaPearl201W012023-01-19
00810725020012Ameda, Inc.17146M17146M2016-09-24
00810725020081Ameda, Inc.17170M17170M2016-09-27
00810725020104Ameda, Inc.17148PM17148PM2016-09-24
00810725020111Ameda, Inc.17358M17358M2016-09-27
00810725020524Ameda, Inc.17105171052016-09-24
00810725020579Ameda, Inc.17150171502016-09-24
00810725020586Ameda, Inc.171512016-09-24
00810725020593Ameda, Inc.17152171522016-09-24

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