Procure 1002225

GUDID 30840330700475

Small Volume Nebulizer W/Adult Aerosol Mask 7' Kink Resistant Tubing Standard Connector

Twin Med, LLC

Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use Nebulizing system delivery set, single-use

• Primary Device ID: 30840330700475
• NIH Device Record Key: 3bf18fe8-50cb-4285-8718-cf59f04e9e3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procure
• Version Model Number: 1002225
• Catalog Number: 1002225
• Company DUNS: 107071289
• Company Name: Twin Med, LLC
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com
• Phone: 612-819-1635
• Email: sanderson@twinmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840330700471 [Primary]
GS1	30840330700475 [Package]; Contains: 10840330700471; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800562

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2022-11-11
• Device Publish Date: 2022-11-03

On-Brand Devices [Procure]

• 30840330700772: Trach Tie Adult, w/moisture repellent material, plush backing for additional comfort, reduces sk
• 30840330700765: Trach Tie Adult, 100% hypoallergenic, w/moisture repellent material, Flex for cough reflex, 2 Pi
• 30840330700758: Trach Tie Adult, Foam w/moisture repellent backing, 2 Piece, L 18.5" x W 1"
• 30840330700741: Trach Tie Pediatric/Neonatal, 1 Piece, 100% hypoallergenic, 10 per bag w/3 different colors, pro
• 30840330700734: Trach Tie Pediatric/Neonatal, 2 Piece, 100% hypoallergenic, 10 per bag w/3 different colors, pro
• 30840330700727: Trach Tie Bariatric, w/proprietary material that pulls moisture away from patient, 2 Piece, L 28
• 30840330700710: Trach Tie Large, Foam w/moisture repellent backing, 1 Piece, L 23.5" x W 1.25"
• 30840330700703: Trach Tie Medium, Foam w/moisture repellent backing, 1 Piece, L 18.5" x W 1.25"
• 30840330700697: Trach Tie Small, Foam w/moisture repellent backing, 1 Piece, L 9.5" x W 1.25"
• 30840330700338: Mask Oxygen Adult W/7' Kink Resistant Tubing Standard Connector
• 30840330700321: Mask Pediatric Tracheostomy
• 30840330700314: Mask Adult Tracheostomy
• 30840330700307: Mask Adult Face Tent
• 30840330700291: Mask Aerosol Pediatric Vented W/O Tubing
• 30840330700284: Mask Adult Aerosol (Vented)
• 30840330700277: DRY BUBBLE HUMIDIFIER HIGH FLOW 6 - 20 LPM
• 30840330700260: Concentrator Bubble Humidifier Elbow Adaptor
• 30840330700253: DRY BUBBLE HUMIDIFIER LOW FLOW Up To 6 LPM
• 30840330700246: HMEF Adult Inline Mini W/Sampling Port 150 - 1000 ML VT Range 26.77 ml Dead Space
• 30840330700239: HMEF Adult In-Line Maxi HMEF W/out Port 350 - 1500 ML VT Range 49.15 ml Dead Space
• 30840330700222: HMEF Adult In-Line Maxi W/Sampling Port 350 - 1500 ML VT Range 49.15 ml Dead Space
• 30840330700215: HME In-Line Mini W/Sampling port 150 - 1000 ML VT Range 29.77 ml Dead Space
• 30840330700208: Bacterial/Viral Filter
• 30840330700192: Hepa Filter W/CO2 port
• 30840330700185: HMEF Straight Small W/Sampling Port 150 - 1500 VT Range 35.3 ml Dead Space
• 30840330700178: HME Adult Straight Small W/out Port
• 30840330700161: HME Pediatric Straight W/Sampling Port 150 - 1500 VT Range 24.3 ml Dead Space
• 30840330700154: Oxygen Cannula Adult Miro Low Flow W/ 7' Kink Resistant Tubing Standard Connector
• 30840330700147: Oxygen Cannula Pediatric W/7' Kink Resistant Tubing Standard Connector
• 30840330700130: Oxygen Cannula Pediatric W/7' Kink Resistant Tubing Standard Connector
• 30840330700123: Oxygen Cannula Adult Standard Prongs W/ 21' Kink Resistant Tubing Standard Connector
• 30840330700116: E-Z Wrap Ear Wraps for Cannulas. 50/cs
• 30840330700109: Comfort Soft Plus Adult Cannula Soft Harness Soft Prongs W/2' Kink Resitant Tubing Standard Conn
• 30840330700093: Comfort Soft Plus Adult Nasal Cannula Soft Tubing Harness Soft Prongs W/7' Tubing Universal Conn
• 30840330700086: Oxygen Cannula Adult Soft Prongs W/7' Kink Resistant Green Tubing Standard Connector
• 30840330700079: Oxygen Cannula Adult Soft Prongs W/7' Kink Resistant Green Tubing Standard Connector
• 30840330700062: Comfort Soft Plus Cannula Adult High Flow W/7' Kink Resistant Tubing Standard Connector
• 30840330700055: Comfort Soft Plus Adult Nasal Cannula Soft Tubing Harness Soft Prongs W/2" Hard Connector
• 30840330700048: Comfort Plus Adult Cannula Soft Reservoir Soft Prongs W/7' Kink Resistant Tubing Standard Connec
• 30840330700031: Comfort Plus Cannula Adult Nasal Cannula Soft Prongs W/25' Kink Resistant Tubing Standard Connec
• 30840330700024: Comfort Soft Plus Adult Cannula Soft Tubing Harness Soft Prongs W/4' Kink Resistant Tubing Stan
• 30840330700017: Comfort Soft Plus Pediatric Cannula Soft Tubing Harness Soft Prongs W/7'Kink Resistant Tubing St
• 30840330700000: Comfort Soft Plus Pediatric Cannula Soft Tubing Harness Soft Prongs 7' Kink Resistant Tubing Uni
• 30840330700604: Oxygen Tubing Kink Resistant 21" W One Standard Connector and One Universal Connector
• 30840330700598: Oxygen Tubing Kink Resistant 14 ' Clear Standard Connectors
• 30840330700581: Oxygen Tubing Kink Resistant 1' Clear Standard Connector
• 30840330700574: Christmas Tree (nipple nut) Connector Green
• 30840330700567: Oxygen Tubing Swivel Connector
• 30840330700550: Oxygen Tubing Connector Barbed
• 30840330700543: Oxygen Tubing Kink Resistant 25' Green Standard Connectors