Midstream Urine Collector

Basic Information

• Brand Name: Midstream Urine Collector
• Primary DI: 00801741051197
• Version / Model: 842801
• Catalog Number: 842801
• Company Name: C. R. Bard, Inc.
• Labeler DUNS: 016898496
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-21
• Public Version: 2
• Public Version Date: 2021-12-09
• Public Version Status: Update
• Public Device Record Key: cdd1311c-680f-49af-bfc4-ccd9106aa390
• Distribution End Date: 2021-10-13

Device Description

Mid-stream Urine Collector with Rigid Funnel and Benzalkonium Chloride Towelettes

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMH	CONTAINER, SPECIMEN, STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47775	General specimen container IVD, no additive/medium	An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10801741051194	GS1	CA	50	Not in Commercial Distribution	2021-10-13
Primary	00801741051197	GS1

Customer Contacts

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