Carum 61.00.74

GUDID 00814079021053

The ARDO Carum powered breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for multiple users.

Ardo medical AG

Breast pump, electric
Primary Device ID00814079021053
NIH Device Record Key0790191e-f266-4b28-b23f-0fecef8aa986
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarum
Version Model Number61.00.74
Catalog Number61.00.74
Company DUNS481670396
Company NameArdo medical AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+414174547070
Emailinfo@ardo.ch
Phone+414174547070
Emailinfo@ardo.ch

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100814079021053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGXPump, Breast, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-02

On-Brand Devices [Carum]

00814079021053The ARDO Carum powered breast pump is intended to be used by lactating women to express and coll
00814079020605The ARDO Carum powered breast pump is intended to be used by lactating women to express and coll

Trademark Results [Carum]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARUM
CARUM
79160281 4920060 Live/Registered
Ardo medical AG
2014-11-12
CARUM
CARUM
71182386 0176079 Dead/Cancelled
Standard Oil Company (Incorporated in New Jersey)
1923-06-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.