Tubing 2M Single

GUDID 07612367007061

Tubing 2 M Single. Model No. MAJ-103 K. 3920733

Medela AG

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• Primary Device ID: 07612367007061
• NIH Device Record Key: b25cd765-ac43-48a2-b476-795edbc86da0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tubing 2M Single
• Version Model Number: 080.0051
• Company DUNS: 488293218
• Company Name: Medela 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612367007061 [Package]; Contains: 07612367051132; Package: 080.0050 [50 Units]; In Commercial Distribution
GS1	07612367010719 [Package]; Contains: 07612367051132; Package: 080.0051 [50 Units]; In Commercial Distribution
GS1	07612367051132 [Primary]
GS1	07612367078214 [Package]; Contains: 07612367051132; Package: 080.0051 [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150134

FDA Product Code

• BTA: Pump, Portable, Aspiration (Manual Or Powered)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-06-07

Devices Manufactured by Medela AG

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• 07612367038713 - Standard rail universal holder: 2024-06-11 Universal clamp with standard rail
• 07612367000109 - Silicone tubing ID 6.5mm, 180cm, 1 coupling piece: 2024-06-10 Silicone tubing ID 6.5mm, 180cm, 1 coupling piece
• 07612367003551 - Quiver 280mm: 2024-06-10 Quiver 280mm
• 07612367003568 - Quiver 480mm: 2024-06-10 Quiver 480mm
• 07612367003575 - Change over valve: 2024-06-10 Change over valve
• 07612367003698 - Overflow protection device: 2024-06-10 Overflow protection device
• 07612367003735 - Reusable serial connector: 2024-06-10 Reusable serial connector