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
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
00814079022203Double Clinic Pumpset63.00.55563.00.5552023-09-06
00814079022210Double Clinic Pumpset63.00.55563.00.5552023-09-06
07640108051516Bellis63.00.52463.00.5242023-05-24
07640108053961Alyssa to-go63.00.51163.00.5112023-05-24
00814079021862Tulips Size S63.00.2363.00.232023-05-23
00814079022104Tulips Size S63.00.32363.00.3232023-05-23
07640109059627Tulips Size S63.00.2363.00.232023-05-23
00814079022111Tulips Size S63.00.32363.00.3232023-05-23
00814079020698Tulip Size M63.00.1563.00.152018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809108019097SpectraUZINMEDICARE CO.,LTDHGY2025-10-15
00810104130936 Wave Single Manual Pump KitWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130950Wave, Container 5oz, ReplacementWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130967Wave, Gasket, 2 pack, RetailWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130974Wave, Flapper Valves, 4 pack, RetailWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130981Wave, Flange 24mm, ReplacementWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104130998Wave, Single, Tubing Set, RetailWILLOW INNOVATIONS, INC.HGY2025-07-23
00810104131001Wave, Handle, ReplacementWILLOW INNOVATIONS, INC.HGY2025-07-23
00194346442294PARENT’S CHOICEWAL-MART STORES, INC.HGY2025-05-12
00810104130790Silicone Wearable Breast PumpWILLOW INNOVATIONS, INC.HGY2025-04-28
09420060214017New Mum Premium Pack - Grey CapTHINK GREEN LIMITEDHGY2024-12-17
09420060214024New Mum Breastfeeding Essentials Pack - Grey CapTHINK GREEN LIMITEDHGY2024-12-17
09420060214031Gen. 2 Silicone Leakproof Pump & Ladybug Milk Collector Combo - 100ml Gen. 2 + 7THINK GREEN LIMITEDHGY2024-12-17
09420060214048Gen. 2 Silicone Leakproof Pump & Ladybug Milk Collector Combo - 150ml Gen. 2 + 7THINK GREEN LIMITEDHGY2024-12-17
09420060214109Silicone Pump & Milk Collector New Baby ComboTHINK GREEN LIMITEDHGY2024-12-17
09420060201581Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - Pea GreenTHINK GREEN LIMITEDHGY2024-12-16
09420060201598Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - OatTHINK GREEN LIMITEDHGY2024-12-16
09420060201604Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - ApricotTHINK GREEN LIMITEDHGY2024-12-16
09420060201611Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - LavenderTHINK GREEN LIMITEDHGY2024-12-16
09420060201628Gen. 2 Silicone Breast Pump & Flower Stopper Set - 100ml - BlushTHINK GREEN LIMITEDHGY2024-12-16
09420060201635Gen. 2 Silicone Breast Pump & Flower Stopper Set - 150ml - Pea GreenTHINK GREEN LIMITEDHGY2024-12-16
09420060201642Gen. 2 Silicone Breast Pump & Flower Stopper Set - 150ml - OatTHINK GREEN LIMITEDHGY2024-12-16
09420060201659Gen. 2 Silicone Breast Pump & Flower Stopper Set - 150ml - ApricotTHINK GREEN LIMITEDHGY2024-12-16
09420060201666Gen. 2 Silicone Breast Pump & Flower Stopper Set - 150ml - LavenderTHINK GREEN LIMITEDHGY2024-12-16
09420060201673Gen. 2 Silicone Breast Pump & Flower Stopper Set - 150ml - BlushTHINK GREEN LIMITEDHGY2024-12-16
09420060201314Gen. 1 Silicone Breast Pump & Cap Set - BlushTHINK GREEN LIMITEDHGY2024-12-12
09420060201420Gen. 3 Multifunctional Silicone Breast Pump & Silicone Cap - 160ml - Grey Ring -THINK GREEN LIMITEDHGY2024-12-12
09420060201437Gen. 3 Multifunctional Silicone Breast Pump & Silicone Cap - 160ml - Peach Ring THINK GREEN LIMITEDHGY2024-12-12
09420060201444Gen. 3 Multifunctional Silicone Breast Pump & Silicone Cap - 250ml - Grey Ring -THINK GREEN LIMITEDHGY2024-12-12
09420060201468New Mum Starter Pack (Non-Vent Cap)THINK GREEN LIMITEDHGY2024-12-12