Recopad

Basic Information

• Brand Name: Recopad
• Primary DI: 00850017881150
• Version / Model: Small Adult
• Company Name: Medfire Innovations Inc.
• Labeler DUNS: 047283094
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-20
• Public Version: 1
• Public Version Date: 2021-05-28
• Public Version Status: New
• Public Device Record Key: b4d517dc-ab74-4f38-97bb-656622c74c02

Device Description

Urine collection kit - Urine sample collection device for basic urinalysis for dependent patients

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58177	Urine specimen collection kit IVD	A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850017881167	GS1	Case	10	In Commercial Distribution
Primary	00850017881150	GS1

Customer Contacts

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