FDA.reportPublic FDA data

18mm PersonalFit™ Plus Breast shields

Primary DI
20020451464576
Brand
18mm PersonalFit™ Plus Breast shields
Company
MEDELA, INC.
Model
101046457
Published
2024-05-21
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHHBreast Pump Kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20020451464576PackageGS16In Commercial Distribution
00020451464572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2002045146457620020451464576
00020451464572000204514645720204514645720020451464572

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump support kit, reusableA 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 infant feeding bottle. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-435-8316customer.service@medela.com

Regulatory Flags#

DUNS number
052002029
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10020451416240Solo™1010416242024-05-15
10020451467099Swing Maxi™ Hands-free1010467092024-05-14
20020451463623Pediatric Breast Pump Kit with Harmony1010463622024-05-08
20020451464477Breast Pump Kit with Harmony & 80mL container1010464472024-05-08
20020451101303ENFit Syringe 1mlENF01LD1010331592024-05-06
20020451100603Enteral FeedingENPU-16-402016-09-22
20020451331083Enteral FeedingENPU16402017-12-20
10020451101719Enteral FeedingENFDUALCAPCNSLD2017-01-27
20020451100894Enteral FeedingINT-CAP2016-09-22
20020451101181Enteral FeedingTL-CAP2016-09-22
10020451101467Enteral FeedingENFMEDCAPNSLD2016-09-22
20020451101709Enteral FeedingENFDUALCAPCLD2017-01-27
00020451463445Colostrum Protector1010463442023-11-01
20020451457837Hands-free Breast shields, 27mm1010457832023-10-30
20020451101402Enteral FeedingENFCAPLD2016-09-22
20020451101419Enteral FeedingENFDUALCAPLD2016-09-22
10020451101429Enteral FeedingENFDUALCAPNSLD2016-09-22
20020451101433Enteral FeedingENFFEMALELD2016-09-22
20020451101440Enteral FeedingENFMALELD2016-09-22
20020451101457Enteral FeedingENFMEDCAPLD2016-09-22

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