SKIN TEMP PROBE (REUSABLE) OMP008

GUDID 00841034117285

RPI

Electrocardiographic lead set, reusable

• Primary Device ID: 00841034117285
• NIH Device Record Key: 920d5b8f-6556-4411-ac04-b529e8c191e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKIN TEMP PROBE (REUSABLE)
• Version Model Number: OMP008
• Catalog Number: OMP008
• Company DUNS: 066232067
• Company Name: RPI
• 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: 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

Customer Support Contacts

• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com
• Phone: 818-882-8611
• Email: techsupport@rpiparts.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841034117285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020219

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

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: 2016-12-09

On-Brand Devices [SKIN TEMP PROBE (REUSABLE)]

• 00841034117322: OMP012
• 00841034117315: OMP011
• 00841034117285: OMP008
• 00841034103226: AIP135
• 00841034103196: AIP132
• 00841034103134: AIP064
• 00841034103127: AIP063