Precision 9500SA

GUDID 10884527006823

Catheter Urine Specimen System Kit

Cardinal Health, Inc.

Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD Midstream urine specimen container IVD

• Primary Device ID: 10884527006823
• NIH Device Record Key: f3b18358-d1df-4d3c-8816-a6a5ce6e4f84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision
• Version Model Number: 9500SA
• Catalog Number: 9500SA
• Company DUNS: 080935429
• Company Name: Cardinal Health, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884527006823 [Package]; Contains: 30884527006827; Package: CASE [100 Units]; In Commercial Distribution
GS1	20884527006820 [Package]; Contains: 30884527006827; Package: PACK_OR_INNER_PACK [25 Units]; In Commercial Distribution
GS1	30884527006827 [Primary]

FDA Product Code

• FMH: Container, Specimen, Sterile
• LIO: Device, specimen collection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-15
• Device Publish Date: 2018-06-30

On-Brand Devices [Precision]

• 10884527006823: Catheter Urine Specimen System Kit
• 20884527006813: Stool Collector
• 10884527006083: Specimen Container,Positive Seal Indicator, OR Packaged
• 10884527006052: Specimen Container,Plastic Screw Top Cap, OR Packaged
• 10884527006007: Specimen Container,Plastic Screw Top Cap
• 10884527005987: Specimen Container,Metal Screw Top Cap, ID Label
• 30884527004939: Specimen Container,Positive Seal Indicator
• 40884527005957: Urine Specimen System with Preservative
• 20884527006103: Midstream Preservative Kit
• 20884527004895: Tissue Grinder
• 20884527004888: Tissue Grinder
• 20884527006448: Sputum Collector Kit with Tube
• 10884527004928: Specimen Container,Positive Seal Indicator