Pulse Oximeter Probe

GUDID 10816317024106

LNCS Infant Probe

RENU MEDICAL, INC

Pulse oximeter probe, reprocessed

• Primary Device ID: 10816317024106
• NIH Device Record Key: 612baac6-673d-4b7c-9a9f-7873bee6b35a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulse Oximeter Probe
• Version Model Number: RM-2328
• Company DUNS: 100439103
• Company Name: RENU MEDICAL, INC
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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	00816317024109 [Primary]
GS1	10816317024106 [Package]; Contains: 00816317024109; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081927

FDA Product Code

• NLF: Oximeter, Reprocessed

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: 2023-08-29
• Device Publish Date: 2023-08-21

Devices Manufactured by RENU MEDICAL, INC

• 00816317024291 - Kendall ECG Leads: 2025-05-09 Cardinal Health Kendall Philips INTEL TELE LEAD SET WITH SHOWER SHIELD 5 Lead 5 Pin 50in
• 10816317024304 - Kendall ECG Leads: 2025-05-09 Cardinal Health Kendall - RADIOLUCENT LD WIRES 5 LEAD 6 Pin 36in
• 00816317024314 - Kendall ECG Leads: 2025-05-09 Cardinal Health Kendall - RADIOLUCENT LD WIRES 5 LEAD 6 Pin 72in
• 10816317024328 - Kendall ECG Leads: 2025-05-09 Cardinal Health Kendall - RADIOLUCENT LD WIRES, 5 LEAD 10 Pin 72in
• 10816317024335 - Kendall ECG Leads: 2025-05-09 Cardinal Health Kendall - RADIOLUCENT LD WIRES, 5 LEAD 10 Pin 36in
• 10816317024342 - Kendall ECG Leads: 2025-05-09 Covidien Kendall - DUAL CONNECT LEADSET 3 LEAD 10 pin 36in
• 10816317024359 - Kendall ECG Leads: 2025-05-09 Covidien Kendall - DISPOSIBLE PH V TELEMETRY 5 LEAD 10 Pin 39in
• 10816317024366 - Kendall ECG Leads: 2025-05-09 Cardinal Health - Kendall, DUAL CONNECT SYSTEM, 6-LEAD 12 Pin 144in