Ameda

Primary DI
00810725022405
Brand
Ameda
Company
AMEDA, INC.
Model
HygieniKit Plus
Catalog number
17451
Published
2021-04-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHHBreast Pump Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHHBreast Pump KitObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011519000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011519000AMEDA HYGIENIKITHollister, Inc.2001-08-15HGY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810725025437PackageGS112In Commercial Distribution
00810725022405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810725025437008107250254378107250254370810725025437
00810725022405008107250224058107250224050810725022405

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump support kit, single-useA collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and milk collection containers (e.g., bottle, cup). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
078719435
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04713530091351MAYMOMMAYMOM LLCOHH2026-09-24
04713530091368MAYMOMMAYMOM LLCOHH2026-09-24
04713530091375MAYMOMMAYMOM LLCOHH2026-09-24
04713530091382MAYMOMMAYMOM LLCOHH2026-09-24
04713530091399MAYMOMMAYMOM LLCOHH2026-09-24
04713530091405MAYMOMMAYMOM LLCOHH2026-09-24
04713530091481MAYMOMMAYMOM LLCOHH2026-09-24
04713530091498MAYMOMMAYMOM LLCOHH2026-09-24
04713530091511MAYMOMMAYMOM LLCOHH2026-09-24
04713530091528MAYMOMMAYMOM LLCOHH2026-09-24
04713530091535MAYMOMMAYMOM LLCOHH2026-09-24
04713530091542MAYMOMMAYMOM LLCOHH2026-09-24
04713530091559MAYMOMMAYMOM LLCOHH2026-09-24
04713530092068MAYMOMMAYMOM LLCOHH2026-09-24
04713530092440MAYMOMMAYMOM LLCOHH2026-09-24
04713530092471MAYMOMMAYMOM LLCOHH2026-09-24
04713530093683MAYMOMMAYMOM LLCOHH2026-09-24
04713530093690MAYMOMMAYMOM LLCOHH2026-09-24
04713530094802MAYMOMMAYMOM LLCOHH2026-09-24
04713530095168MAYMOMMAYMOM LLCOHH2026-09-24
04713530095359MAYMOMMAYMOM LLCOHH2026-09-24
04713530095366MAYMOMMAYMOM LLCOHH2026-09-24
04713530096479MAYMOMMAYMOM LLCOHH2026-09-24
04713530097056MAYMOMMAYMOM LLCOHH2026-09-24
04713530097063MAYMOMMAYMOM LLCOHH2026-09-24
04713530102323MAYMOMMAYMOM LLCOHH2026-09-24
04713530102330MAYMOMMAYMOM LLCOHH2026-09-24
04713530102347MAYMOMMAYMOM LLCOHH2026-09-24
04713530102354MAYMOMMAYMOM LLCOHH2026-09-24
04713530102361MAYMOMMAYMOM LLCOHH2026-09-24