Ameda

Primary DI
00810725025437
Brand
Ameda
Company
AMEDA, INC.
Model
HygieniKit Plus
Catalog number
17451
Published
2021-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
false

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-use, sterileA collection of sterile 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, and connectors. This is a single-use device.

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
false
Manufacturing date on label
true
Expiration date on label
true
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

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