Pediatric Breast Pump Kit with Harmony

GUDID 20020451463623

MEDELA, INC.

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• Primary Device ID: 20020451463623
• NIH Device Record Key: d9e3d912-b3dd-4447-8b97-921d9a5c26ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pediatric Breast Pump Kit with Harmony
• Version Model Number: 101046362
• Company DUNS: 052002029
• Company Name: MEDELA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00020451463629 [Primary]
GS1	20020451463623 [Package]; Contains: 00020451463629; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• OHH: Breast Pump Kit

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: 2024-05-16
• Device Publish Date: 2024-05-08

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• 20020451463623 - Pediatric Breast Pump Kit with Harmony: 2024-05-16
• 20020451463623 - Pediatric Breast Pump Kit with Harmony: 2024-05-16
• 20020451464477 - Breast Pump Kit with Harmony & 80mL container: 2024-05-16