Healthline Medical Inc. - Asthma Rescue Kit

Basic Information

• Brand Name: Healthline Medical Inc. - Asthma Rescue Kit
• Primary DI: 00850022357015
• Version / Model: ARK-7
• Company Name: Medi/Nuclear Corporation, Inc.
• Labeler DUNS: 079628327
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-09
• Public Version: 1
• Public Version Date: 2020-11-17
• Public Version Status: New
• Public Device Record Key: a339536b-a2b5-470d-9fe0-98ed9f0ccfa4

Device Description

Asthma Rescue Kit, Pediatric Mask, HEPA MnM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31309	Nebulizing system delivery set, single-use	A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850022357459	GS1		5	In Commercial Distribution
Primary	00850022357015	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K080657	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: store at room temperature