Pertrach

GUDID 10841470100077

PULMODYNE INC

Cricothyrotomy kit, single-use

• Primary Device ID: 10841470100077
• NIH Device Record Key: 82807470-6c89-4fef-b8df-662f31a3f44f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pertrach
• Version Model Number: 313-D4555
• 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

Customer Support Contacts

• Phone: 317-246-5500
• Email: info@pulmodyne.com

Device Dimensions

• Lumen/Inner Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470100070 [Primary]
GS1	10841470100077 [Package]; Contains: 00841470100070; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914743

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-20

On-Brand Devices [Pertrach]

• 10841470100107: 313-D4559
• 10841470100091: 313-D4557
• 10841470100084: 313-D4556
• 10841470100077: 313-D4555
• 10841470100060: 313-D4554
• 10841470100053: 313-D4553
• 10841470100046: 313-D4552
• 10841470100039: 313-D4551
• 10841470100022: 313-D4550
• 10841470100015: 313-D4558