Syringe, Luer, 5cc, 5-pack

Basic Information

• Brand Name: Syringe, Luer, 5cc, 5-pack
• Primary DI: 00851607003259
• Version / Model: RMD-010-006
• Company Name: MEDSPIRA, LLC
• Labeler DUNS: 962187964
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-01
• Public Version: 1
• Public Version Date: 2021-07-09
• Public Version Status: New
• Public Device Record Key: 2a5d3fa1-29d5-4698-b824-e718bb13ee55

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLA	Monitor, Esophageal Motility, Anorectal Motility, And Tube	Gastroenterology, Urology	876.1725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35053	Manometric gastrointestinal motility analysis system	An assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851607003259	GS1
Package	10851607003256	GS1	Shipper	5	In Commercial Distribution

Customer Contacts

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