Ptensys Bleeding Control Station TM-400

GUDID 00855204008020

Ptensys Bleeding Control Station

TYTEK MEDICAL INC.

First aid kit, non-medicated, single-use

• Primary Device ID: 00855204008020
• NIH Device Record Key: 349d9ebd-6a40-4d65-8d58-b829e77bba61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ptensys Bleeding Control Station
• Version Model Number: TM-400
• Catalog Number: TM-400
• Company DUNS: 078589992
• Company Name: TYTEK MEDICAL INC.
• Device Count: 1
• 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: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855204008020 [Primary]

FDA Product Code

• OHO: First Aid Kit Without Drug

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: 2019-10-11
• Device Publish Date: 2019-10-03

Devices Manufactured by TYTEK MEDICAL INC.

• 00860010987902 - Surgical HypoHolder: 2025-07-07 Magnetic pin and handle base
• 00860010987940 - Clinical HypoHolder: 2025-07-07 Non-sterile pin base for use in clinical setting
• 00860010987926 - HypoPan: 2025-06-25 Autoclave pan and tray for Surgical HypoHolder
• 00860013471606 - HypoFoam: 2025-06-25 Single-use foam block for use with HypoHolder system
• 00855204008006 - TPAK: 2019-10-11 Tension Pneumothorax Decompression Needle: 14 gauge x 3.25"
• 00855204008013 - TVAC: 2019-10-11 Disposable portable suction unit
• 00855204008020 - Ptensys Bleeding Control Station: 2019-10-11Ptensys Bleeding Control Station
• 00855204008020 - Ptensys Bleeding Control Station: 2019-10-11 Ptensys Bleeding Control Station
• 00855204008037 - Ptensys Bleeding Control Kits: 2019-10-11 Ptensys Bleeding Control Kits