Mini-Heart

GUDID 10709078008198

Mini-Heart Hi-Flo Continuous Nebulizer, Super Spike Mask, 7'

WESTMED, INC.

Nebulizing system delivery set, reusable

• Primary Device ID: 10709078008198
• NIH Device Record Key: fe3a902d-eaab-4e9c-b683-0d972e76daaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini-Heart
• Version Model Number: 100625
• Company DUNS: 092673953
• Company Name: WESTMED, 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078008191 [Primary]
GS1	10709078008198 [Package]; Contains: 00709078008191; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920443

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: 2019-11-08
• Device Publish Date: 2019-10-31

Devices Manufactured by WESTMED, INC.

• 00709078049996 - Filter: 2025-10-01 Entered in error
• 00709078050008 - Filter: 2025-10-01 Entered in error
• 10709078008402 - Flex Extenders: 2024-10-03 Flex Extender, 5.2" x 15mm OD x 22/15mm ID
• 20889483562786 - Disposable Anesthesia Breathing Circuit: 2024-09-16 Breathing Circuit, Pediatric, 60", Parallel Wye w/Port
• 20889483612009 - Anesthesia Circuit Kit: 2024-06-10 60" Adult Anesthesia Circuit; Swivel Wye, 2L LF Bag
• 20889483612016 - Anesthesia Circuit Kit: 2024-06-10 60" Adult Anes. Circuit; Par-Wye, GSE, 2L Latex Free
• 20889483612023 - Anesthesia Circuit Kit: 2024-06-10 60" Pediatric Anes. Circuit, Par-Wye, GSE W/Port
• 20889483612030 - Anesthesia Circuit Kit: 2024-06-10 UniLim,120" Adult.Coa.Circuit,Elbow,24Flex Expiratory