Tempheart 060534

GUDID H29740091

MEAS Tempheart® Shields

MEASUREMENT SPECIALTIES, INC.

Adhesive bandage

• Primary Device ID: H29740091
• NIH Device Record Key: d0beb2c3-6dd2-4e83-8af1-4d7e36ab1d14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tempheart
• Version Model Number: 4009
• Catalog Number: 060534
• Company DUNS: 029351079
• Company Name: MEASUREMENT SPECIALTIES, INC.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H29740090 [Unit of Use]
HIBCC	H29740091 [Primary]

FDA Product Code

• KGX: Tape And Bandage, Adhesive

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: 2018-10-22
• Device Publish Date: 2018-09-21

Devices Manufactured by MEASUREMENT SPECIALTIES, INC.

• H29740091 - Tempheart: 2018-10-22MEAS Tempheart® Shields
• H29740091 - Tempheart: 2018-10-22 MEAS Tempheart® Shields
• H2974010 - Reusable GP Temperature Probe: 2018-10-22 Reusable Temperature Probe – Esophageal/Rectal (Adult)
• 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)