Hospital Kit DeTach 24 mm 63.00.477

GUDID 07640108055521

The Hospital Kit should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The Hospital Kit can be used both as a single pumpset and as a double pumpset and is intended for single users only.

Ardo medical AG

Breast pump support kit, single-use

• Primary Device ID: 07640108055521
• NIH Device Record Key: cf3a18bc-295f-44d5-984d-60c5a2b12ac7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hospital Kit DeTach 24 mm
• Version Model Number: 63.00.477
• Catalog Number: 63.00.477
• Company DUNS: 481670396
• Company Name: Ardo medical AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com
• Phone: +18444112736
• Email: customer-service@ardo-usa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640108055521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172067

FDA Product Code

• HGX: Pump, Breast, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-04
• Device Publish Date: 2025-08-27

Devices Manufactured by Ardo medical AG

• 07640108055507 - Hospital Kit DeTach 21 mm: 2025-09-04 The Hospital Kit should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express an
• 07640108055521 - Hospital Kit DeTach 24 mm: 2025-09-04The Hospital Kit should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The Hospital Kit can be used both as a single pumpset and as a double pumpset and is intended for single users only.
• 07640108055521 - Hospital Kit DeTach 24 mm: 2025-09-04 The Hospital Kit should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express an
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• 07640108053374 - Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115V: 2025-07-24
• 07640108055293 - Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115V: 2025-07-24
• 07640108054470 - Alyssa Hands-Free: 2024-01-30 Breast Pump, electric, with hands-free-pumpset
• 07640108054494 - Hands-Free Double Pumpset: 2024-01-30 The Ardo Hands-Free Double Pumpset should be used in combination with the Ardo breastpumps and is intended for the expression an
• 00814079022210 - Double Clinic Pumpset: 2023-09-14 The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express an