FDA.reportPublic FDA data

Breast shell sterile DeTach 15 mm (2 pcs)

Primary DI
07640108055965
Brand
Breast shell sterile DeTach 15 mm (2 pcs)
Company
Ardo medical AG
Model
63.00.486
Catalog number
63.00.486
Device description
Additional size of breast shield/shell for pumpsets/pumpkits DeTach.
Published
2026-07-31
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
HGXPump, Breast, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172067000One Mum PumpsetArdo Medical AG2017-11-29HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640108055965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640108055965076401080559657640108055965

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
+18444112736customer-service@ardo-usa.com
+41417547070info@ardo.ch

Regulatory Flags#

DUNS number
481670396
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
false
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
07640108055903Breast shell sterile DeTach 12 mm (2 pcs)63.00.48363.00.4832026-07-31
07640108055927Breast shell sterile DeTach 13 mm (2 pcs)63.00.48463.00.4842026-07-31
07640108055941Breast shell sterile DeTach 14 mm (2 pcs)63.00.48563.00.4852026-07-31
07640108055989Breast shell sterile DeTach 16 mm (2 pcs)63.00.48763.00.4872026-07-31
07640108056009Breast shell sterile DeTach 17 mm (2 pcs)63.00.48863.00.4882026-07-31
07640108055545Breast shell sterile DeTach 18 mm (2 pcs)63.00.47863.00.4782026-07-30
07640108055569Breast shell sterile DeTach 21 mm (2 pcs)63.00.47963.00.4792026-07-30
07640108055583Breast shell sterile DeTach 24 mm (2 pcs)63.00.48063.00.4802026-07-30
07640108054975Ardo Melia63.00.57163.00.5712026-02-27
07640108054982Ardo Melia63.00.57163.00.5712026-02-27
07640108051080Alyssa Hands-Free to-go63.00.51363.00.5132025-09-15
07640108055507Hospital Kit DeTach 21 mm63.00.47663.00.4762025-08-27
07640108055521Hospital Kit DeTach 24 mm63.00.47763.00.4772025-08-27
07640108052506Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit Fussschalter30.00.22 / UP033C30.00.222025-07-16
07640108053374Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115V31.00.22 / UP030C31.00.222025-07-16
07640108055293Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115V30.00.24 / UP034C30.00.242025-07-16
07640108054470Alyssa Hands-Free63.00.45363.00.4532024-01-22
07640108054494Hands-Free Double Pumpset63.00.45463.00.4542024-01-22
00814079020094Amaryll63.00.19063.00.1902022-08-04
00814079020872Double Clinic Pumpset63.00.28363.00.2832016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640108055903Breast shell sterile DeTach 12 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055927Breast shell sterile DeTach 13 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055941Breast shell sterile DeTach 14 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055989Breast shell sterile DeTach 16 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108056009Breast shell sterile DeTach 17 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055545Breast shell sterile DeTach 18 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055569Breast shell sterile DeTach 21 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055583Breast shell sterile DeTach 24 mm (2 pcs)Ardo medical AGHGX2026-07-30
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