Medline

Basic Information

• Brand Name: Medline
• Primary DI: 00884389106870
• Version / Model: HCS70004
• Catalog Number: HCS70004
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-04
• Public Version: 1
• Public Version Date: 2022-08-12
• Public Version Status: New
• Public Device Record Key: c79589a6-8321-4a0f-8d7c-aa3b50327ecc

Device Description

COMPRESSOR,NEBULIZER,AEROMIST COMPACT

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
BTI	Compressor, air, portable	Anesthesiology	868.6250	2
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	40884389106878	GS1	CASE	8	In Commercial Distribution
Primary	00884389106870	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 62 – 110 KiloPascal