CareTouch

GUDID 00370393908017

manufctrue for Nobel supplies Group .

Hunan Accurate Bio-Medical Technology Co., Ltd.

Pulse oximeter, battery-powered

• Primary Device ID: 00370393908017
• NIH Device Record Key: 4114ad09-2253-4156-8be2-ab1684f4b341
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareTouch
• Version Model Number: CTOM
• Company DUNS: 421349331
• Company Name: Hunan Accurate Bio-Medical Technology 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: true
• Lot Batch: true
• 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	00370393908017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141105

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-27

Devices Manufactured by Hunan Accurate Bio-Medical Technology Co., Ltd.

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