simplicare

GUDID 06973912940525

Fingertip Pulse Oximeter

IMDK

Pulse oximeter

• Primary Device ID: 06973912940525
• NIH Device Record Key: c4bd9b83-6150-497d-ab33-eaf5772ab0ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: simplicare
• Version Model Number: C101A2
• Company DUNS: 544547964
• Company Name: IMDK
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973912940525 [Primary]

FDA Product Code

• OCH: Oximeter, Infrared, Sporting, Aviation

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: 2025-12-11
• Device Publish Date: 2025-12-03

Devices Manufactured by IMDK

• 06973912940525 - simplicare: 2025-12-11Fingertip Pulse Oximeter
• 06973912940525 - simplicare: 2025-12-11 Fingertip Pulse Oximeter
• 06973912940013 - IMDK: 2022-05-24 Fingertip Pulse Oximeter
• 06973912940020 - IMDK: 2022-05-24 Ultrasonic Doppler Fetal Heart Rate Detector
• 06973912940037 - IMDK: 2022-05-24 Fingertip Pulse Oximeter
• 06973912940044 - IMDK: 2022-05-24 Fingertip Pulse Oximeter
• 06973912940051 - IMDK: 2022-05-24 Ultrasonic Doppler Fetal Heart Rate Detector
• 06973912940068 - IMDK: 2022-05-24 Fingertip Pulse Oximeter
• 06973912940075 - IMDK: 2022-05-24 Fingertip Pulse Oximeter