FDA.reportPublic FDA data

Amaryll

Primary DI
00814079020094
Brand
Amaryll
Company
Ardo medical AG
Model
63.00.190
Catalog number
63.00.190
Device description
Manual Breast Pump (until stock runs out)will be replaced: Amaryll Start (Catalog Number: 63.00.191)
Published
2022-08-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGYPump, Breast, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGYPump, Breast, Non-PoweredObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814079020100PackageGS110Not in Commercial Distribution
00814079020094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814079020100008140790201008140790201000814079020100
00814079020094008140790200948140790200940814079020094

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, manualA hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+18444112736customer-service@ardo-usa.com
+41417547070info@ardo.ch

Regulatory Flags#

DUNS number
481670396
Device count
1
Premarket exempt
true
Lot or batch
true

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
07640108055965Breast shell sterile DeTach 15 mm (2 pcs)63.00.48663.00.4862026-07-31
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
00814079020872Double Clinic Pumpset63.00.28363.00.2832016-09-22

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