Hopkins Medical Products Handheld Pulse Oximeter 594810

GUDID 00817643023071

HOPKINS UNIFORM COMPANY

Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter 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