Precision

Basic Information

• Brand Name: Precision
• Primary DI: 10884527004607
• Version / Model: 2205SA
• Catalog Number: 2205SA
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 400
• Record Status: Published
• Publish Date: 2018-06-29
• Public Version: 2
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: 7841d8e9-6d00-4eac-9fee-34c483c8113e

Device Description

Specimen Container,Positive Seal Indicator

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Expiration Date: No
• 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
12542	Midstream urine specimen container IVD	A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of first-voided urine is diverted to a separate reservoir for discarding. Additional items may be included (e.g., towelettes). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884527004607	GS1
Unit of Use	20884527004604	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	4	Fluid Ounce
Width	2	Inch
Height	3.5	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry;AVOID DIRECT SUNLIGHT