Surelife

GUDID MHC18603103

MHC MEDICAL PRODUCTS, LLC

Pulse oximeter probe, single-use

• Primary Device ID: MHC18603103
• NIH Device Record Key: 114915b3-c1ba-43d5-b230-2ef79fa3546e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surelife
• Version Model Number: 860310
• Company DUNS: 169895245
• Company Name: MHC MEDICAL PRODUCTS, LLC
• 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: true
• 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
HIBCC	MHC18603102 [Primary]
HIBCC	MHC18603103 [Package]; Contains: MHC18603102; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141105

FDA Product Code

• DQA: Oximeter
• OCH: Oximeter, Infrared, Sporting, Aviation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-10
• Device Publish Date: 2018-01-22

On-Brand Devices [Surelife]

• MHC18602142: 860214
• MHC18602132: 860213
• MHC18602122: 860212
• MHC18602112: 860211
• MHC18603203: 860320
• MHC18603103: 860310