Adapter, Rubber, 1 3/8 TO 7/8

Basic Information

• Brand Name: Adapter, Rubber, 1 3/8 TO 7/8
• Primary DI: 00817081022865
• Version / Model: Adapter, Rubber, 1 3/8 TO 7/8 - 113600
• Catalog Number: 113600
• Company Name: A-M SYSTEMS, LLC
• Labeler DUNS: 020275145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-10
• Public Version: 4
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: ea1e3f5f-85eb-4247-ab13-ad243344916d

Device Description

Adapter, Tube, Blue Autoclavable Thermoplastic Rubber, 1 3/8 TO 7/8

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYP	Mouthpiece, Breathing	Anesthesiology	868.5620	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43467	Breathing mouthpiece, reusable	A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. The device accepts or attaches to, either directly or through other tubes/adapters, diagnostic/therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device which may be intended for single- or multi-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00817081022872	GS1		3	In Commercial Distribution
Primary	00817081022865	GS1

Customer Contacts

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