Unimed

GUDID 06945664818216

Disposable SpO2 Sensor/Adhesive/Nonin/Adult+Neonate/0.9M/LOGOMED

Unimed Medical Supplies, Inc.

Pulse oximeter probe, single-use

• Primary Device ID: 06945664818216
• NIH Device Record Key: ad229961-fecf-4bc4-abd1-425d56127eba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unimed
• Version Model Number: U543-08 (RU2)*
• Company DUNS: 527971025
• Company Name: Unimed Medical Supplies, Inc.
• 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: true
• 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
GS1	06945664818216 [Primary]
GS1	16945664818213 [Package]; Package: Carton box [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142832

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-23

On-Brand Devices [Unimed]

• 06945664884754: ECG Monitor Trunk Cable/Marquette/HP type/5-lead/AHA/3.0M/060/MAC
• 06945664884747: ECG Monitor Lead Wire/DX type/3-lead/grabber/AHA/0.9M/MAC
• 06945664884730: ECG Monitor Lead Wire/D type/5-lead/grabber/AHA/0.9M/1st CALL
• 06945664884723: ECG Monitor Lead Wire/DX type/5-lead/Snap/AHA/0.9M/MAC
• 06945664884716: ECG Monitor Trunk Cable/Philips/MQ type/10-lead/AHA/2.2M/333/Pacific
• 16945664884706: Disposable ECG moniter lead wire/MR type/5-lead/Grabber/AHA/0.9M/CSM
• 06945664884693: DECG interface cable/ GE /11pin/2.5M/Pacific
• 06945664884686: ECG Monitor Lead wire/MR style/5-lead/Snap/AHA/0.9M/DTG
• 06945664884679: One piece ECG Monitor Cable/Marquette/5-lead/grabber/AHA/2.5M+0.9M/060/MAC
• 06945664884662: EKG Adaptor/4.0 banana plug-duck mouth ECG Adaptor/Green(10PCS/bag)/Partssource
• 06945664884655: EKG Diagnosis Lead Wire/Philips type/10-lead/banana plug/AHA/1.2M+0.8M/Jaken Medical
• 06945664884648: One piece EKG Diagnosis Cable/Burdick/10-lead/4mm banana plug/AHA/2.2M+1.2M*4+0.8M*6/332/Jaken
• 06945664884631: One piece EKG Diagnosis Cable/Philips/10-lead/4mm banana plug/AHA/2.2M+1.2M*4+0.8M*6/333/Jaken
• 06945664884624: One piece EKG Diagnosis Cable/Quinton/10-lead/grabber/AHA/3.6M+1.2M*4+0.8M*6/050/Jaken Med
• 06945664884617: One piece ECG Monitor Cable/AAMI 6Pin/5-lead/Snap/AHA/2.5M+0.9M/001/MAC
• 16945664884607: Disposable ECG Lead Wires/SL style/5-lead/Grabber/AHA/IEC/0.9M
• 16945664884591: Disposable ECG Lead Wires/CDM style/5-lead/Snap/AHA/0.9M/Pacific
• 06945664884587: EKG Diagnosis Lead Wire/AA style/10-lead/grabber/AHA/1.2M+0.9M/Pacific
• 06945664884570: ECG Monitor Lead Wire/DT type/5-lead/grabber/AHA/0.9M/MAC
• 06945664884563: ECG Monitor Trunk Cable/Mindray/MR type/5-lead/AHA/2.5M/358/MAC
• 16945664884553: Disposable ECG moniter lead wire/Philips MX40/5-lead/Grabber/AHA/0.9M
• 06945664884549: ECG Monitor Lead Wire/HOLTER/D type/7-lead/Snap/AHA/0.9M/Pacific
• 06945664884532: ECG Monitor Lead Wire/MQ type/6-lead/Snap/AHA/0.9M/Pacific
• 06945664884525: Reusable SpO2 Sensor/Minolta/Finger Clip/Adult//0.3M/346/Pacific
• 06945664884518: ECG Monitor Trunk Cable//Colin/CL type/5-lead/AHA/2.5M/092/Pacific
• 06945664884501: One piece ECG Monitor Cable/Philips/5-lead/Grabber/AHA/2.5M+0.9M/024/TENACORE
• 06945664884495: ECG Monitor Trunk Cable/Spacelabs/SL type/5-lead/AHA/2.5M/038/MAC
• 06945664884488: ECG Monitor Lead Wire/Fukuda Denshi/3-lead/snap/IEC/0.9M
• 16945664884478: Disposable ECG moniter lead wire/AA type Telemetry/3-lead/Grabber/AHA/0.9M/CSM
• 06945664884464: ECG Monitor Trunk Cable/Fukuda Denshi/FD type/5-lead/AHA/2.5M/535
• 16945664884454: Disposable ECG moniter lead wire/CDM type/3-lead/Snap/AHA/3.1M/Sage Services GROUP
• 06945664884440: ECG Monitor Trunk Cable/AAMI 6Pin/D type/3-lead/AHA/2.5M/001
• 06945664884433: One piece EKG Diagnosis Cable/Welch Allyn/10-lead/4mm banana plug/IEC/0.6M+1.2M*4+0.8M*6/LP14
• 06945664884426: ECG Monitor Lead Wire/SL type/3-lead /snap/AHA/0.9M/Pacific
• 06945664884419: One piece EKG Diagnosis Cable/Marquette/10-lead/4mm banana plug/AHA/2.2M+1.2M*4+0.8M*6/330/Coast
• 06945664884402: ECG Monitor Lead Wire/SM type/5-lead /grabber/AHA/0.9M/Pacific
• 06945664884396: ECG Monitor Lead Wire/MQ type/3-lead /grabber/AHA/0.9M/1st CALL
• 06945664884389: ECG Monitor Lead Wires Adaptor/S&W-CD style type 5-lead/Sage Services GROUP
• 06945664884372: ECG Monitor Lead Wires Adaptor/SL-CD style type 10-lead/Sage Services GROUP
• 06945664884365: ECG Monitor Lead Wires Adaptor/MQ style 6 lead-CD style type 6-lead/Sage Services GROUP
• 06945664884358: ECG Monitor Lead Wires Adaptor/MQ style 5 lead-CD style type 5-lead/Sage Services GROUP
• 06945664884341: ECG Monitor Lead Wires Adaptor/MQ-CD style type 5-lead/Sage Services GROUP
• 06945664884334: ECG Monitor Lead Wires Adaptor/HP style 5 lead-CD style type 5-lead/Sage Services GROUP
• 06945664884327: ECG Monitor Lead Wires Adaptor/HP-CD style type 5-lead/Sage Services GROUP
• 06945664884310: ECG Monitor Lead Wire/MR type/5-lead limb/grabber/IEC/0.9M
• 06945664884303: ECG Monitor Lead Wire/MR type/5-lead Chest/grabber/IEC/0.9M
• 06945664884297: ECG Monitor Trunk Cable/AAMI 6Pin/DX type/5-lead/AHA/2.5M/001/Pacific
• 06945664884280: GE Lead 1.4 Socket pin electrode long wire/straight connector/1.3M
• 16945664884270: Disposable ECG Lead Wires/CDM style/10-lead/Snap/AHA/3.1M/Sage Services GROUP
• 16945664884263: Disposable ECG Lead Wires/CDM style/5-lead/Snap/AHA/3.1M/Sage Services GROUP