K082959

GUDID 06945664812412

SpO2 interface cable/Philips-Masimo/2.2M/309+126/MasimoLNOP/TENACORE

Unimed Medical Supplies, Inc.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 06945664812412
• NIH Device Record Key: e7e63499-4a8a-4761-96da-4b76bbe96c8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K082959
• Version Model Number: TCEO-0412-0922
• Company DUNS: 527971025
• Company Name: Unimed Medical Supplies, Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945664812412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082959

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-23

Devices Manufactured by Unimed Medical Supplies, Inc.

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• 06936735450534 - Unimed: 2024-10-28 Repetitive SpO2 probe/Nellcor-OXIMAX/soft finger cuff/adult/3.0M/103X/pluscare
• 06936735450541 - Unimed: 2024-10-28 Repetitive SpO2 Probe/Nihon Kohden/Finger Clip/Adult/3.0M/LP9-40B
• 06936735451463 - Unimed: 2024-10-28 Reusable SpO2 Sensor Nonin Compatible Adult Finger Clip
• 06936735451470 - Unimed: 2024-10-28 Disposable Adhesive Elastic Textile SpO2 Sensors M Tech Compatible Infant
• 06936735451487 - Unimed: 2024-10-28 Reusable Neonate Wrap SpO2 Sensor Creative-OXIMAX Compatible