Maxtec

GUDID 00817770021285

MAXTEC, LLC

Respiratory oxygen sensor Respiratory oxygen sensor

• Primary Device ID: 00817770021285
• NIH Device Record Key: 641447ae-cffd-4a17-9e76-335f595e932a
• Commercial Distribution Discontinuation: 2019-01-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Maxtec
• Version Model Number: PS2000
• Company DUNS: 169911828
• Company Name: MAXTEC, 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817770021285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972992

FDA Product Code

• CCL: Analyzer, Gas, Oxygen, Gaseous-Phase

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: 2019-01-11
• Device Publish Date: 2017-01-10

Devices Manufactured by MAXTEC, LLC

• 10817770021121 - SmartStack: 2023-10-18 IV Pole 8 Pack
• 00817770020561 - EyeMax2: 2023-06-20 EyeMax2 Kit (Contains a 20/pack each of Regular, Preemie, and Micro)
• 00817770020974 - Flowmeter: 2023-06-20 0-70 LMP Oxygen Flowmeter NPT Female Fitting 60 PSI White Knob
• 00817770025818 - EyeMax2: 2023-06-20 EyeMax2 Micro 20/Pack Italian (Italian Label)
• 00817770025825 - EyeMax2: 2023-06-20 EyeMax2 Preemie Italian 20/Pack (Italian Label)
• 00817770025832 - EyeMax2: 2023-06-20 EyeMax2 Regular 20/Pack (Italian Label)
• 00817770022213 - SmartStack: 2023-06-16 SmartStack Bundle
• 00817770022220 - SmartStack: 2023-06-16 SmartStack Bundle with Dual Tank Holder