SpO2 Adapter Cable

GUDID 06941691924050

Nellcor-Oximax Compatible, 2.4M

Orantech Inc.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 06941691924050
• NIH Device Record Key: 79ca69e8-3f2f-41b7-8c4d-adff0b566932
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpO2 Adapter Cable
• Version Model Number: SA-001X-24
• Company DUNS: 544423370
• Company Name: Orantech 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	06941691924050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182327

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-04
• Device Publish Date: 2020-12-25

On-Brand Devices [SpO2 Adapter Cable]

• 06941691924586: Philips Compatible, 2.4M
• 06941691924555: Philips Compatible, 2.4M
• 06941691924357: GE Marquette Compatible, 2.4M
• 06941691924050: Nellcor-Oximax Compatible, 2.4M