TytoCare Pulse Oximeter

GUDID 06945040105251

TytoCare Pulse Oximeter (IL)

Contec Medical Systems Co., Ltd.

Pulse oximeter

• Primary Device ID: 06945040105251
• NIH Device Record Key: 8bcb7ce0-6ec7-450b-a4b2-7e7614d83362
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TytoCare Pulse Oximeter
• Version Model Number: CMS50DA+
• Company DUNS: 529606295
• Company Name: Contec Medical Systems Co., Ltd.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945040105251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082641

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-10
• Device Publish Date: 2020-11-11

On-Brand Devices [TytoCare Pulse Oximeter]

• 06945040105251: TytoCare Pulse Oximeter (IL)
• 06945040105244: TytoCare Pulse Oximeter
• 06945040105237: TytoCare Pulse Oximeter