Res-Q-Vac

Basic Information

• Brand Name: Res-Q-Vac
• Primary DI: 00659443000933
• Version / Model: PHC
• Catalog Number: PHC
• Company Name: REPRO MED SYSTEMS, INC.
• Labeler DUNS: 048403299
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 4
• Public Version Date: 2018-08-23
• Public Version Status: Update
• Public Device Record Key: 54d707c5-4f1c-4c33-9325-73075b91ad93

Device Description

Plastic Hospital Clamp

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
BSY	CATHETERS, SUCTION, TRACHEOBRONCHIAL	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47368	Emergency airway clearance suction system, manual	A portable assembly of devices, which includes a non-surgical invasive component, intended to manually aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes a manually-powered (hand or foot-operated) suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00659443000933	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K894299	000