Alyssa

Primary DI
07640108053541
Brand
Alyssa
Company
Ardo medical AG
Model
63.00.509
Catalog number
63.00.509
Device description
Breast Pump, electric
Published
2022-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
K212773000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212773000ARDO AlyssaArdo Medical AG2022-04-15HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640108053541PackageGS14In Commercial Distribution
07640108053534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640108053541076401080535417640108053541
07640108053534076401080535347640108053534

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, electricA mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

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
false
Serial number
true
Manufacturing date on label
false
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
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
00814079020094Amaryll63.00.19063.00.1902022-08-04

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
07640108055965Breast shell sterile DeTach 15 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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