Metered Dose Straight Swivel

Basic Information

• Brand Name: Metered Dose Straight Swivel
• Primary DI: 00858409005405
• Version / Model: MC-1523
• Catalog Number: MC-1523
• Company Name: Medicomp
• Labeler DUNS: 154454730
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-11
• Public Version: 3
• Public Version Date: 2023-01-10
• Public Version Status: Update
• Public Device Record Key: 63e8b313-6582-4768-85b8-5fe8aff83949

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Serial Number: No
• 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
BZA	Connector, Airway (Extension)	Anesthesiology	868.5810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62680	Medicine chamber spacer, single-use	A non-sterile device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic, paper, or cardboard and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise be deposited in the mouth/upper airway, but are intended for the lower airway. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20858409005409	GS1	case	25	Not in Commercial Distribution	2023-01-09
Primary	00858409005405	GS1
Package	10858409005402	GS1	case	50	In Commercial Distribution