Hopkins Medical Products Handheld Pulse Oximeter 594810

GUDID 00817643023071

HOPKINS UNIFORM COMPANY

Pulse oximeter

• Primary Device ID: 00817643023071
• NIH Device Record Key: 6d2ba19c-183d-4b62-aa64-51f8d2745766
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hopkins Medical Products Handheld Pulse Oximeter
• Version Model Number: Y Probe
• Catalog Number: 594810
• Company DUNS: 003080678
• Company Name: HOPKINS UNIFORM COMPANY
• 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: 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	00817643023071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171241

FDA Product Code

• DQA: Oximeter

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: 2022-05-16
• Device Publish Date: 2022-05-06

Devices Manufactured by HOPKINS UNIFORM COMPANY

• 00817643023071 - Hopkins Medical Products Handheld Pulse Oximeter: 2022-05-16
• 00817643023071 - Hopkins Medical Products Handheld Pulse Oximeter: 2022-05-16
• 10817643020145 - Hopkins Medical Products®: 2020-05-06 Procedure Mask PK50
• 10817643020534 - Hopkins Medical Products®: 2020-05-06 Procedure Mask With Eyeshield 25/PK
• 00817643020148 - Hopkins Medical Products®: 2020-05-06 Disposable Procedure Mask Each
• 00817643020537 - Hopkins Medical Products®: 2020-05-06 Procedure Mask With Eyeshield Each
• 00817643021558 - Hopkins Medical Products®: 2020-05-06 Total Readiness Kit – Latex Free
• 00817643021596 - Hopkins Medical Products®: 2020-05-06 Disposable Personal Protection Kit
• 00817643021602 - Hopkins Medical Products®: 2020-05-06 Head To Toe Disposable Personal Protection Kit