Control-Cric

GUDID 10841470109063

PULMODYNE INC

Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use Cricothyrotomy kit, single-use

• Primary Device ID: 10841470109063
• NIH Device Record Key: 58ca4a66-402d-4f94-bf11-ffc9aab34ee2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control-Cric
• Version Model Number: 313-4567
• Company DUNS: 030619483
• Company Name: PULMODYNE 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470109066 [Primary]
GS1	10841470109063 [Package]; Contains: 00841470109066; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830509

FDA Product Code

• BTO: Tube, Tracheostomy (W/Wo Connector)

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: 2021-10-08
• Device Publish Date: 2021-09-30

Devices Manufactured by PULMODYNE INC

• 10841470100718 - VT Select: 2023-04-18
• 10841470100749 - VT Select: 2023-04-18
• 10841470100770 - VT Select: 2023-04-18
• 10841470100794 - VT Select: 2023-04-18
• 10841470100817 - VT Select: 2023-04-18
• 10841470106505 - BiTrac SE Select: 2022-04-05
• 10841470100282 - DART: 2022-04-04
• 10841470100299 - DART: 2022-04-04