8001 Series Skin Temperature Probe 8001-063-401

GUDID H29780010634012

8001 Series Skin Temperature Probe

MEASUREMENT SPECIALTIES, INC.

General-purpose patient temperature probe, single-use

• Primary Device ID: H29780010634012
• NIH Device Record Key: d87d370b-e131-4340-bb5f-791aae40fc5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8001 Series Skin Temperature Probe
• Version Model Number: 8001-063-401
• Catalog Number: 8001-063-401
• Company DUNS: 029351079
• Company Name: MEASUREMENT SPECIALTIES, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-899-9783
• Email: medfeedback@te.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H29780010634010 [Primary]
HIBCC	H29780010634011 [Package]; Contains: H29780010634010; Package: Inner Box [20 Units]; In Commercial Distribution
HIBCC	H29780010634012 [Package]; Contains: H29780010634011; Package: Outer Box [10 Units]; In Commercial Distribution

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-19
• Device Publish Date: 2016-07-01

Devices Manufactured by MEASUREMENT SPECIALTIES, INC.

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• H29740100 - Extension Cable: 2018-10-22 10’ Extension Cable (400 Series)
• H29740121 - Mini Tempheart: 2018-10-22 MEAS Mini-Tempheart® Shields
• H2974020 - Reusable GP Temperature Probe: 2018-10-22 Reusable Temperature Probe – Esophageal/Rectal (Pediatric)
• H2974030 - Reusable Tubular Temperature Probe: 2018-10-22 .157” dia. S. S. Tubular Reusable Temperature Probe
• H2974060 - Reusable Tubular Temperature Probe: 2018-10-22 .125” dia. S. S. Tubular Reusable Temperature Probe
• H297409A0 - Reusable Skin Temperature Probe: 2018-10-22 Reusable Temperature Probe – Skin (Adult)