PneumoDart TM-317

GUDID 00855204008167

Superior Tension Pneumothorax Decompression Needle

TYTEK MEDICAL INC.

Body aspiration needle, single-use

• Primary Device ID: 00855204008167
• NIH Device Record Key: 1361a1e5-0e03-4f78-ad3c-dd67f146db34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PneumoDart
• Version Model Number: TM-317
• Catalog Number: TM-317
• 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	00855204008167 [Primary]

FDA Product Code

• GAA: Needle, Aspiration And Injection, Disposable

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

Devices Manufactured by TYTEK MEDICAL INC.

• 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: 2019-10-11 Ptensys Bleeding Control Station
• 00855204008037 - Ptensys Bleeding Control Kits: 2019-10-11 Ptensys Bleeding Control Kits
• 00855204008051 - TPAK: 2019-10-11 Tension Pneumothorax Decompression Needle: 10 gauge x 3.25"
• 00855204008068 - TYTEK TRAUMA BANDAGE: 2019-10-11 4" Trauma Bandage
• 00855204008075 - TYTEK TRAUMA BANDAGE: 2019-10-11 6" Trauma Bandage
• 00855204008082 - TYTEK TRAUMA BANDAGE: 2019-10-11 Abdominal Trauma Bandage