ThermaSolutions TMP-1308

GUDID 00851450007121

Temperature probe-pouch with two TMP-1304

THERMASOLUTIONS, INC.

General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use

• Primary Device ID: 00851450007121
• NIH Device Record Key: ef407d59-ceec-4091-bfaa-fe665098bc2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermaSolutions
• Version Model Number: TMP-1308
• Catalog Number: TMP-1308
• Company DUNS: 186855925
• Company Name: THERMASOLUTIONS, 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: false
• 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: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com
• Phone: +1-877-952-6100
• Email: info@thermasolutions.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851450007121 [Primary]
GS1	10851450007128 [Package]; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101244

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-14
• Device Publish Date: 2021-05-06

On-Brand Devices [ThermaSolutions]

• 00851450007121: Temperature probe-pouch with two TMP-1304
• 00851450007114: Temperature probe-single TMP-1304
• 00851450007305: FLW-0120
• 00851450007268: FLW-0010
• 00851450007244: PAK-0112
• 00851450007237: FLW-0111